Search Clinical Trials
Before medications are approved by the U.S. Food and Drug Administration (FDA) or before certain therapy methods are widely accepted as effective, they are tested on people who volunteer to participate in a clinical trial.
Organizations across the country are looking for people like you to take part in their research studies. The list of studies below have been selected from ClinicalTrials.gov based on their inclusion of one or more of the following terms: anxiety disorders, depression, OCD, PTSD, and bipolar disorder.
The Anxiety and Depression Association of America (ADAA) is supportive of research that is conducted through clinical trials. Participating in research can potentially help change the mental health outcomes for you and others who suffer anxiety, depression, and related disorders. You may learn about new interventions/treatments that are being considered.
Read this ADAA blog about things to know and questions to ask before committing to a clinical trial.
This website page is brought to you in partnership with ResearchMatch.
Sponsor Condition of Interest |
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Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketami1
National Institute of Mental Health (NIMH)
Healthy Volunteer
Major Depressive Disorder
Depression
Background:
Most medications that treat depression take weeks or months to work. Researchers want to
develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect.
For most people, this lasts a week or less. Repeated doses of ketamine may help maintain
this effect.
Object1 expand
Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: - Medical and psychiatric history - Psychiatric and physical exam - Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): - Gradually stop current medications - MRI: Participants lie and perform tasks in a machine that takes pictures of the body. - Mood and thinking tests - Blood and urine tests - Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. - Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. - Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): - 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): - 8 infusions of ketamine over 4 weeks Phase IV (optional): - Symptoms monitoring for 4 weeks - Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: - Medical and psychiatric history - Psychiatric and physical exam - Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry Type: Interventional Start Date: May 2017 |
Meditative Neurofeedback for Depression
University of California, San Diego
Depression - Major Depressive Disorder
Depression Disorders
The goal of this open-label single-arm study is to test a meditative neurofeedback
intervention for depressed mood. expand
The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood. Type: Interventional Start Date: Nov 2024 |
Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
University of California, Los Angeles
Posttraumatic Stress Disorder (PTSD)
Anxiety
Depression - Major Depressive Disorder
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD)
present major threats to public health. PTSD and SUD are major correlates of disability,
often resulting in severe social and occupational impairment. Comorbidity between PTSD
and SUD (PTSD/SUD) is common and fr1 expand
Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Comorbidity between PTSD and SUD (PTSD/SUD) is common and frequently co-occurs with other mental health ailments including depression, anxiety, and suicidality. Comorbidity may be amplified in groups vulnerable to high trauma exposure, such as women with low socioeconomic status including women experiencing homelessness (WEH). Moreover, the reciprocal nature of PTSD/SUD (substances are used to cope with PTSD symptoms; substance use can create high-risk situations for new traumas to occur), can create a cycle of trauma and symptomatology leading to a critical health disparity. PTSD/SUD can be costly and difficult to treat, with treatment completion often low and relapse rates often high. Low-cost, complementary interventions, such as self-compassion (SC) interventions, which target key mechanisms that maintain PTSD/SUD, could improve treatment outcomes. SC interventions include practices that build skills to improve emotional responses, cognitive understanding, and mindfulness. Recent research supports the benefit of SC interventions for reducing PTSD, SUD, and related comorbidities, potentially with large effects. However, sample sizes have generally been small and randomized designs infrequently used. Moreover, while SC interventions may act to improve key mechanisms of treatment response and/or symptom maintenance (e.g., emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving), such mediating factors have been underexplored. To address these limitations, the present proposal will implement community-based research principles and use a two phase, mixed-method design to adapt and test a widely used SC intervention (Mindful Self Compassion; MSC) for use with a sample of WEH with PTSD/SUD. The project will be conducted in partnership with a state-funded drug treatment facility that serves women and families experiencing high health disparities. Phase I was completed in 2023 and adapted the standard MSC course for use with trauma-exposed WEH with PTSD/SUD using the ADAPT-ITT model, an eight-stage model that engages community partners to increase feasibility and acceptability of interventions for at-risk populations. Phase II will be an open-label cluster randomized clinical trial (N=202) to test the benefit of the adapted MSC at improving primary (PTSD, substance use) and secondary outcomes (depression, anxiety, hopelessness) among a sample of WEH with PTSD/SUD residing in a residential drug treatment site. MSC (n=101) will be compared to Treatment as Usual (TAU; n=101). WEH in the MSC group will complete a 6-week (six sessions plus a half-day retreat) MSC intervention. The TAU group will engage in weekly check-ins with the research team but will not receive an intervention. WEH will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up. One-on-one interviews will be conducted with the MSC group to collect qualitative data on experiences. An exploratory aim will be to elucidate mechanism of treatment-response and maintenance or remission of PTSD symptoms. These potential mechanisms will include SC, emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving. Results may inform treatment for PTSD/SUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSD/SUD symptoms over time. Findings are relevant to military populations, which experience high rates of PTSD/SUD, and other populations disproportionately exposed to trauma. Type: Interventional Start Date: May 2024 |
Evaluation of Teen Connection Project for Trans and Gender Minority Youth
University of Nebraska Lincoln
Recreational Drug Use
Sexual Violence
Victimisation
Depressive Symptoms
Anxiety
The purpose of this project is to develop and evaluate an online mentoring and
skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18,
the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated
by transgender and/or gender minority (TG1 expand
The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions. Type: Interventional Start Date: Jul 2024 |
A Study to Test Different Doses of BI 1569912 in People With Depression
Boehringer Ingelheim
Depressive Disorder, Major
This study is open to adults between 18 and 65 years of age with a type of depression
called major depressive disorder. The purpose of the study is to find out whether a
medicine called BI 1569912 helps people with depression.
Participants are put into 4 groups randomly, which means by chance. Thr1 expand
This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects. Type: Interventional Start Date: Oct 2024 |
Rare Group Problem Management Plus
Children's National Research Institute
Anxiety
Depressive Symptoms
Post-traumatic Stress Disorder
Problems Psychosocial
Participants are being asked to be in the study if they are the parent or legal guardian
of a child (>1 year or <18 years old) with a rare condition.
The group based psychoeducational intervention is called Rare Group Problem Management
Plus.
Rare Group PM Plus may help adults with practical and1 expand
Participants are being asked to be in the study if they are the parent or legal guardian of a child (>1 year or <18 years old) with a rare condition. The group based psychoeducational intervention is called Rare Group Problem Management Plus. Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes) Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour. Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this. Participants will not receive any materials or money or medication. Type: Interventional Start Date: Feb 2024 |
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar1
Neumora Therapeutics, Inc.
Major Depressive Episode Associated With Bipolar II Disorder
This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the
effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II
disorder. The study design consists of a Screening Period (up to 28 days), a 6-week
Treatment Period (during which particip1 expand
This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period. Type: Interventional Start Date: May 2024 |
Mood and Thought Process Study
Butler Hospital
Depression in Remission
Depressive Symptoms
Depression
The primary objective for this project is to test whether affective executive functioning
is a mechanism of action of mindfulness-based cognitive therapy and Wellness for
Wellbeing. The main questions it aims to answer are:
1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhib1 expand
The primary objective for this project is to test whether affective executive functioning is a mechanism of action of mindfulness-based cognitive therapy and Wellness for Wellbeing. The main questions it aims to answer are: 1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (i.e., emotionally valenced inhibition as measured via the affective Go/No Go task) using an RCT. 2. Test the effect of MBCT vs. Wellness for Wellbeing on (a) affective updating and (b) affective shifting. Outcomes will be measured with the affective n-Back and the affective Internal Switching Task, respectively. 3a) The investigators will examine whether depression symptom severity co-varies with change in affective executive functioning (i.e., affecting inhibition, shifting, and updating) over time. 3b) The investigators will examine whether compliance with treatment protocol (e.g., number of classes attended, amount of home practice) predicts endpoint executive functioning. Participants will complete surveys, interviews, and computer tasks, and will be randomized to either Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing. Type: Interventional Start Date: Apr 2023 |
Benzodiazepine Taper with Cognitive Behavioral Therapy in Patients Using Prescription Opioids
University of California, Los Angeles
Anxiety Disorders
Taking prescription opioids for pain together with benzodiazepines for the treatment of
anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA)
because of the elevated risk of serious complications, including fatal overdose. However,
this concurrent prescription use cont1 expand
Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality. Type: Interventional Start Date: Apr 2023 |
The Effect of Celecoxib on Neuroinflammation in MDD
Stony Brook University
Major Depressive Disorder
Neuroinflammation
Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is
a leading contributor to global disease burden. Commonly used monoamine
reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of
patients achieving remission. This may be because m1 expand
Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of patients achieving remission. This may be because monoamine dysfunction is not the primary pathophysiology in all MDD patients. One avenue for the development of novel MDD treatments is through anti-inflammatory drugs; MDD is linked to a pro-inflammatory phenotype characterized by microglial activation, leading to the release of pro-inflammatory cytokines and upregulation of cellular markers including cyclooxygenase-2 (COX-2) and translocator protein (TSPO; a protein located on the outer membrane of microglia). Relevant to this proposal, TSPO can serve as an in vivo marker of neuroinflammation using the newly developed positron emission tomography (PET) tracer for TSPO, [18F]FEPPA. In support of this, a recent [18F]FEPPA PET study found that MDD patients in a current major depressive episode (MDE) had significantly higher TSPO binding in the prefrontal cortex (PFC), anterior cingulate cortex (ACC) and insula, relative to healthy controls. The prefrontal cortex and ACC are both implicated in mood regulation whereas the insula is involved in interoceptive signaling, which is known to be abnormal in MDD. Celecoxib, a selective COX-2 nonsteroidal anti-inflammatory drug (NSAID), is a promising new treatment for neuroinflammation in MDD. Clinical studies have observed that, in a subset of depressed patients, celecoxib treatment reduced depression severity as assessed by the Hamilton Depression Rating Scale (HDRS). While these findings demonstrate that celecoxib reduces symptom severity, PET imaging technology is critical for understanding how celecoxib affects the underlying pathophysiology of depression. Here, the team will investigate neuroinflammation as an underlying pathology in depression and test whether neuroinflammation is reduced by celecoxib in MDD patients. Specifically, in the proposed pilot study, MDD patients in a current MDE will receive [18F]FEPPA PET scans prior to and following 8 weeks of treatment with 400mg/day of celecoxib, with HDRS scores obtained at each time point. The investigators hypothesize that following celecoxib treatment, patients will show a significant reduction in neuroinflammation in the PFC, ACC and insula, which will correlate positively with the reduction in depressive symptoms, as measured by the HDRS. The proposed study will use novel imaging technology, [18F]FEPPA PET, to measure the effects of celecoxib on neuroinflammation in MDD patients. Our results will help to 1) identify neuroinflammation as an underlying pathology in MDD and 2) test whether reduction of inflammation is the mechanism of action of celecoxib. As such, the results of this study will aid in the development of targeted clinical treatments to improve remission rates in MDD patients. Type: Interventional Start Date: Aug 2018 |
Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy
Montefiore Medical Center
PTSD
This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy
(TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who
have not responded to standard treatment at the VA. expand
This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not responded to standard treatment at the VA. Type: Interventional Start Date: Nov 2018 |
Defining Neurobiological Links Between Substance Use and Mental Illness
National Institute on Drug Abuse (NIDA)
Major Depressive Disorder
Substance Use Disorder
Normal Physiology
Background:
Nicotine dependence leads to about 480,000 deaths every year in the United States. People
with major depressive disorder (MDD) are twice as likely to use nicotine compared to the
general population. They have greater withdrawal symptoms and are more likely to relapse
after quitting com1 expand
Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD. Objective: To understand how nicotine affects symptoms of depression and related brain function. Eligibility: People aged 18 to 60 years with and without MDD who do not smoke cigarettes or use other nicotine products. Design: Participants will have 2 or 3 study visits over 1 to 3 months. Participants will have 2 MRI scans at least 1 week apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs. Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan. For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours. Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan. They will have a blood test after each scan. Type: Interventional Start Date: Feb 2023 |
The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Children's National Research Institute
Asthma in Children
Depression
The goal of this clinical trial is to test the effectiveness and implementation of
delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal
depression treatment, to mothers of children aged 4-11 years in an urban pediatric asthma
clinic. Researchers will compare Enh1 expand
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children aged 4-11 years in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are: 1. Does Enhanced IPT-B decrease maternal depressive symptoms? 2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)? 3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic? Type: Interventional Start Date: Oct 2024 |
Deep Brain Stimulation of Treatment-Resistant Bipolar Depression
Wayne Goodman MD
Bipolar Depression
This study is only enrolling at Baylor College of Medicine. The other research locations
listed serve to support data analysis only.
This research study is to investigate the use of technology called Deep Brain Stimulation
(DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD)1 expand
This study is only enrolling at Baylor College of Medicine. The other research locations listed serve to support data analysis only. This research study is to investigate the use of technology called Deep Brain Stimulation (DBS) to potentially improve Treatment-Resistant Bipolar Depression (TRBD) symptoms in patients with severe cases. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in TRBD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for TRBD treatment. Its important for participants to understand that this is an investigational study where there could be a lack of effectiveness in improving TRBD symptoms. There may be no directly benefit from taking part in this study. This study is expected to last 20 months and involves 3 main steps. 1. Medical, psychiatric, and cognitive evaluations. 2. Implantation of a brain stimulation system. 3. Follow up after implantation of device, including programming, recording, and psychiatric testing. There are risks and benefits to this study which need to be considered when deciding to participate or not. Some of the risks are from surgery, the DBS device and programming, the tests involved, and potential loss of confidentiality, as well as other unknown risks. Some of the more serious risks involved in this study and the percentage that they occur: 1. Bleeding inside the Brain (1 to 2 percent). 2. Infection from the procedures (3 percent) 3. Seizure caused from the procedures (1.2 percent) However, the benefit of this study is that it may help relieve or decrease TRBD symptoms. This form of treatment has shown to reduce symptom severity in other cases. This could potentially improve quality of life and activities in daily routines. There is also a potential benefit to society in that the data the investigators will obtain from this study may help increase the understanding of the mechanisms underlying TRBD symptoms, as well as enhanced Deep Brain Stimulation techniques. Study participation is expected to last 20 months from the time the DBS device is activated and should include approximately 23 visits. These visits also include 8 separate, 24 hour stays at the Menninger NeuroBehvaioral Monitoring Unit (NBU). These 24-hour sessions will occur at multiple points throughout the study (1 week prior to surgery, the week preceding device activation, the week following activation, then after 2 weeks, 4 weeks, 6 months, 9 months, and 12 months). Participants will need to stay locally for the week of the NBU stay (typically Monday through Friday). Study visits will include clinician administered assessments and questionnaires, subject reported assessments, neuropsychological testing, and mobile behavioral assessments which will occur around 23 visits over the course of 20 months. Type: Interventional Start Date: Nov 2024 |
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
Medical University of South Carolina
Depression
Depressive Symptoms
Cancer
The purpose of this research study is to evaluate a mobile application (app) for
depression treatment called "Moodivate" among cancer survivors. Moodivate was developed
by our research team to assist with the treatment of depressed mood.
Participants will be randomly assigned to either download th1 expand
The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood. Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not. All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today. Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood. Type: Interventional Start Date: Oct 2024 |
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major1
Janssen Research & Development, LLC
Depressive Disorder, Major
The purpose of this study is to know how well seltorexant works, and also to evaluate
safety and maintenance effect of seltorexant compared with placebo as an adjunctive
therapy to an antidepressant in improving depressive symptoms in participants with major
depressive disorder with insomnia sympto1 expand
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Type: Interventional Start Date: Jul 2024 |
Mental Health App for Cancer Survivors Study
University of Wisconsin, Madison
Head and Neck Cancer
Head and Neck Cancers
Depression
The goal of this clinical trial is to adapt a mental health digital app to treat
depression among head and neck cancer patients and survivors.
Participants will download and use the digital mental health app for a 6-week period, and
will complete related surveys. expand
The goal of this clinical trial is to adapt a mental health digital app to treat depression among head and neck cancer patients and survivors. Participants will download and use the digital mental health app for a 6-week period, and will complete related surveys. Type: Interventional Start Date: Nov 2024 |
Imaging Depression in Parkinson's Disease
Yale University
Parkinson's Disease
Major Depressive Disorder
The goal of this observational study is to identify targetable neural substrates of
depression in Parkinson's Disease for the first time in people with Parkinson's between
the ages of 40 and 80, who are experiencing symptoms of depression. expand
The goal of this observational study is to identify targetable neural substrates of depression in Parkinson's Disease for the first time in people with Parkinson's between the ages of 40 and 80, who are experiencing symptoms of depression. Type: Observational Start Date: Sep 2024 |
Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy
University of Florida
Anxiety
Pain, Procedural
Office hysteroscopy is an invaluable practice to treat a myriad of gynecological
processes. However, a limiting factor is the perceived pain and anxiety. In a randomized
pilot study, treatment with lavender aromatherapy will significantly decrease the
stress/anxiety levels associated with office hy1 expand
Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo. Type: Interventional Start Date: Jun 2024 |
Psilocybin for Treatment-Resistant Depression
University of Colorado, Denver
Major Depressive Disorder
Anhedonia
Treatment Resistant Depression
The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of
anhedonia in individuals with treatment-resistant major depressive disorder. expand
The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder. Type: Interventional Start Date: Jul 2024 |
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety a1
Laureate Institute for Brain Research, Inc.
Depression, Anxiety
Fear
Depression
Anxiety and Fear
Anxiety Disorders
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat
processing system and associated brain circuits in people with depression, anxiety
disorders and comorbid depression and anxiety disorders. In a double blind, placebo
controlled crossover design, up to 65 individ1 expand
This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group). All participants will receive a single dose of Lorazepam and placebo (order randomized) taken orally. After the ~2.5 hr screening session, participants will complete two identical ~5 hr experimental sessions, each of which include a 30 min eyeblink startle session and a 1.5 hr functional magnetic resonance imaging (MRI) brain scan session. The total time involved in the study is approximately 10.5 hours. The main questions the study seeks to answer are: - are people with comorbid depression and anxiety different than those with depression alone in terms of their eyeblink startle response to threat? - are people with comorbid depression and anxiety different than those with depression alone in terms of their brain activation in response to threat? - are people with comorbid depression and anxiety different than those with depression alone in terms of their responses to anxiety drugs? Type: Interventional Start Date: Nov 2023 |
Alexithymia Intervention for Suicide
VA Office of Research and Development
Suicide
Schizophrenia
Bipolar Disorder
Post Traumatic Stress Disorder
Major Depressive Disorder
Suicide rates among Veterans with Serious Mental Illness (SMI) are intractably high,
representing a serious public health concern and a critical target for interventions.
Yet, at present available treatments offer modest benefits. Thus, there remains an urgent
need to identify novel approaches to a1 expand
Suicide rates among Veterans with Serious Mental Illness (SMI) are intractably high, representing a serious public health concern and a critical target for interventions. Yet, at present available treatments offer modest benefits. Thus, there remains an urgent need to identify novel approaches to address suicide risk in this population. Previous reports have linked suicide risk with poor social functioning. Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness. Consistent with these findings, individuals with SMI at risk of suicide display social functioning difficulties along with poor emotion awareness (i.e., alexithymia). Employing a proof-of-concept design, the aim of the present study is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention with smartphones designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI. Type: Interventional Start Date: Oct 2023 |
Audio-based Mental Health Intervention Study
Penn State University
Depressive Symptoms
This is a study on an audio-based digital intervention designed to reduce symptoms of
depression. Participants who experience at least moderate symptoms of depression will be
invited to participate in the study. Participants will be randomly assigned to receive
one of two audio-based digital interv1 expand
This is a study on an audio-based digital intervention designed to reduce symptoms of depression. Participants who experience at least moderate symptoms of depression will be invited to participate in the study. Participants will be randomly assigned to receive one of two audio-based digital interventions. The experimental intervention based on behavioral activation treatment for depression. The control intervention is based on self-monitoring. Depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization) Type: Interventional Start Date: Feb 2023 |
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treat1
AbbVie
Depression
Bipolar I Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult
population and 1.8% of the pediatric population in the United States. The treatment of
the depressive episodes of bipolar disorder in the pediatric population has not been as
widely studied as the treatment of dep1 expand
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Apr 2021 |
Very Brief Exposure: Development of a Novel Exposure Modality for Social Anxiety Disorder in Transi1
Children's Hospital Los Angeles
Social Anxiety Disorder
The goal of this clinical trial is to identify the circuit activations by very brief
exposure (VBE) among youth with social anxiety disorder (SAD) in order to develop a novel
intervention for those with SAD. The secondary objectives of this study are to measure
the effect of VBE on subjective fear1 expand
The goal of this clinical trial is to identify the circuit activations by very brief exposure (VBE) among youth with social anxiety disorder (SAD) in order to develop a novel intervention for those with SAD. The secondary objectives of this study are to measure the effect of VBE on subjective fear ratings, and participants' awareness and tolerance of the exposure stimuli. - The primary outcome of this study is the mean activation of frontostriatal and prefrontal brain regions to facial stimuli, as measured by Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest during the magnetic resonance imaging (MRI). - Another primary outcome of the study is to identify networks of regions subserving emotion regulation and attention, as measured by BOLD response of corresponding brain regions. Secondary Outcomes -The secondary outcome of this study is the fear induced by exposure to facial expression stimuli as measured by a 4-point fear scale during the functional magnetic resonance imaging (fMRI) after each block of 10 facial expression stimuli trials. Participants will participate in an interview where they will answer questions both inside and outside of the MRI scan. Participants will be asked to rate on a scale the imagines they see while undergoing MRI scan. Type: Interventional Start Date: Aug 2024 |
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