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. This website page is brought to you in partnership with ResearchMatch.
Sponsor Condition of Interest |
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Slow Wave Induction by Propofol to Eliminate Depression (SWIPED)
Washington University School of Medicine
Treatment Resistant Depression
Our hypothesis is that targeted propofol infusion in TRD patients will induce slow wave
activity during sedation and augment subsequent sleep slow wave activity. We will recruit
15 participants for this open label single arm Phase I trial. All participants will
undergo two propofol infusions 2-6 days... expand
Our hypothesis is that targeted propofol infusion in TRD patients will induce slow wave activity during sedation and augment subsequent sleep slow wave activity. We will recruit 15 participants for this open label single arm Phase I trial. All participants will undergo two propofol infusions 2-6 days apart, with each infusion maximizing expression of EEG slow waves. To minimize bias, there will be no specific gender or ethnic background consideration for enrollment. This will be a single site investigation at Washington University Medical Center. Type: Interventional Start Date: Jan 2021 |
Social Reward and Its Effect on Brain Functions in Psychotherapies for Mid- and Late-Life Depression
Weill Medical College of Cornell University
Major Depressive Disorder
Abnormalities in the Positive Valence System (PVS) are associated with depressive
symptoms and reduced behavioral activation in mid- and late-life. This study will
investigate the engagement of the PVS during exposure to social rewards, part of a novel
streamlined psychotherapy for mid- and late-life... expand
Abnormalities in the Positive Valence System (PVS) are associated with depressive symptoms and reduced behavioral activation in mid- and late-life. This study will investigate the engagement of the PVS during exposure to social rewards, part of a novel streamlined psychotherapy for mid- and late-life depression. Use of computational modeling will enable identification of neuroimaging and behavioral profiles associated with greater treatment response, and may guide future personalization of psychotherapy. Type: Interventional Start Date: Oct 2020 |
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
Massachusetts General Hospital
Major Depressive Disorder
This study will identify the sex-dependent impact of expiratory-gated transcutaneous
vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and
associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80
adults with recurrent MDD randomized... expand
This study will identify the sex-dependent impact of expiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80 adults with recurrent MDD randomized to receive active or sham expiratory-gated tVNS during a functional magnetic resonance imaging (fMRI) session, with simultaneous mood and physiological assessments. We hypothesize that expiratory-gated tVNS will effectively modulate, in a sex-dependent manner, specific brainstem-cortical pathways of the stress circuitry and attenuate physiological deficits in MDD. Type: Interventional Start Date: Jan 2021 |
Vagal Nerve Stimulation in mTBI
VA Office of Research and Development
PTSD
mTBI
Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important
conditions for the Veterans Administration (VA) that frequently occur together in combat
Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become
chronic, raising the risk the burden... expand
Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD. Type: Interventional Start Date: Feb 2021 |
Intervention for IPV-exposed Pregnant Women
University of Notre Dame
Postpartum Depression
Posttraumatic Stress Disorder
Infant Behavior
Violence
Parenting
The overarching goal of the proposed project is to evaluate a randomized clinical trial
of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal
mental health, re-victimization, parenting sensitivity, and infant development. The
project also seeks to examine theoretically-grounded... expand
The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older. The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition). Type: Interventional Start Date: Jul 2019 |
Intranasal Insulin for Posttraumatic Stress Disorder
VA Connecticut Healthcare System
PTSD
To evaluate if intranasal insulin is effective in reducing PTSD symptoms. expand
To evaluate if intranasal insulin is effective in reducing PTSD symptoms. Type: Interventional Start Date: Jul 2024 |
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
University of Texas Southwestern Medical Center
Premature Infant
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Development, Child
Parent-Child Relations
This study is being done to see if outcomes for both a premature infant's parents and the
infant born prematurely who have spent time in the neonatal intensive care unit (NICU)
can be improved through parent cognitive behavioral therapy (CBT) sessions. expand
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions. Type: Interventional Start Date: Apr 2019 |
Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network...
Baylor College of Medicine
Major Depressive Disorder
The goal of the study is to address the unmet need of TRD patients by identifying brain
networks critical for treating depression and to use next generation precision DBS with
steering capability to engage these targeted networks. The study's goal will be achieved
through 3 specific aims:
1.... expand
The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms Type: Interventional Start Date: Aug 2019 |
Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder
Wake Forest University Health Sciences
Anxiety
Pain
Burnout, Professional
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment
option for patients with refractory urgency urinary incontinence (UUI). It is often
performed as an office-based procedure under local anesthesia. Alternatively, it can be
performed in the operating room under general... expand
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population. The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology & Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline. Type: Interventional Start Date: May 2024 |
Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression
Laureate Institute for Brain Research, Inc.
Bipolar Depression
This is a 2x2, within-subjects, cross-over trial to test the anti-depressant effects of
acute exercise in 20 participants with bipolar depression. Participants will complete
four experimental sessions, two with an exercise challenge and two with a resting control
condition in a counterbalanced order.... expand
This is a 2x2, within-subjects, cross-over trial to test the anti-depressant effects of acute exercise in 20 participants with bipolar depression. Participants will complete four experimental sessions, two with an exercise challenge and two with a resting control condition in a counterbalanced order. Participants will receive either 800mg of ibuprofen or placebo before exercise or rest in order to test whether blocking the inflammatory response to exercise interferes with the neural and psychological effects of exercise. Type: Interventional Start Date: Mar 2024 |
Adapting BA for Minimally Verbal Autistic Adults
Rutgers, The State University of New Jersey
Autism
Depression
Autism Spectrum Disorder With Impaired Functional Language
Autism Spectrum Disorder
The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral
activation intervention for people with intellectual disabilities and low mood to be
implemented with minimally verbal autistic individuals. expand
The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with minimally verbal autistic individuals. Type: Interventional Start Date: Nov 2023 |
A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk...
VA Office of Research and Development
TBI
Suicide Prevention
Veterans
PTSD
Transdiagnostic
Risk of Veteran suicide is elevated during the first year of transition from military
service to civilian life. Most Veteran suicides occur among Veterans who are not
connected to VA healthcare. Suicide prevention and connection to care are therefore
critical for recently transitioning Veterans. Transitioning... expand
Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream. Type: Interventional Start Date: Mar 2024 |
Expressive Writing on Minority Stressors Among Sexual Minority Veterans
VA Office of Research and Development
Depressive Symptoms
Anxiety
Sexual minority stressors (e.g., sexual minority identity-based discrimination)
contribute to greater risk for and severity of depression, anxiety, substance use
disorders and suicide among sexual minority Veterans. However, no brief, scalable,
one-on-one interventions targeting sexual minority stressor-related... expand
Sexual minority stressors (e.g., sexual minority identity-based discrimination) contribute to greater risk for and severity of depression, anxiety, substance use disorders and suicide among sexual minority Veterans. However, no brief, scalable, one-on-one interventions targeting sexual minority stressor-related distress are available in Veterans Affairs (VA) for sexual minority Veterans. The proposed research will examine the feasibility, acceptability, and preliminary effectiveness of a brief, 3-session expressive writing intervention to target distress related to sexual minority stressor exposure among sexual minority Veterans. The results of this work will advance knowledge about a promising brief and easy to implement intervention focused on reducing depressive and anxiety symptoms among sexual minority Veterans. This proposal aligns with VA's and CSR&D's commitment to providing equitable services to sexual minority Veterans and the aim of reducing health disparities among underserved Veteran groups. Type: Interventional Start Date: Mar 2024 |
Cognitive and Affective Processes Online
University of Minnesota
Depression
This study will provide data for evaluating the psychometric characteristics of the tests
assessing cognitive flexibility, including their (1) internal consistency, (2)
feasibility and tolerability, their (3) convergent and discriminant validity of cognitive
and affective constructs such as those... expand
This study will provide data for evaluating the psychometric characteristics of the tests assessing cognitive flexibility, including their (1) internal consistency, (2) feasibility and tolerability, their (3) convergent and discriminant validity of cognitive and affective constructs such as those introduced to understand mental disorders, and (4) sensitivity (and correspondence) to individual differences. For these tests to be useful in studying clinical conditions, they must show adequate reliability, validity, and sensitivity in large samples of convenience. Type: Observational Start Date: Feb 2023 |
Preventing Childbirth-Related PTSD With Expressive Writing
Massachusetts General Hospital
PTSD (Childbirth-Related)
The goal of this clinical trial is to test a brief psychological intervention given to
individuals in the first days following childbirth who have experienced a potentially
stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder
following childbirth and promoting... expand
The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding. In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum, participants will take part in mental health and physiological assessments, and in a brief play session with their infant. Type: Interventional Start Date: Nov 2023 |
Behavioral Exposure for Introceptive Tolerance RCT
Rutgers, The State University of New Jersey
Exercise Sensitivity
Introceptive Exposure
Anxiety
Cardiac Rehabilitation
Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed
behavioral intervention to target exercise anxiety. The three primary components of
BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of
safety behavior use before/during/after exercise,... expand
Behavioral Exposure for Interoceptive Tolerance (BE-FIT) is a mechanism-informed behavioral intervention to target exercise anxiety. The three primary components of BE-FIT include: (1) exposure to feared bodily sensations and exercise; (2) prevention of safety behavior use before/during/after exercise, and (3) use of a wrist-worn activity monitor for physical activity (PA) feedback and activity goal setting. Evidence from the investigators' Stage I trial indicated that BE-FIT is feasible, acceptable, and safe and produced reductions in exercise anxiety and increased exercise outcomes (short-term moderate-to-vigorous intensity physical activity and steps/day). The investigators' present aim is to conduct a Stage II randomized-controlled trial to further evaluate the efficacy of BE-FIT in decreasing exercise anxiety in cardiac rehabilitation (CR) patients and examine whether changes in this target yield successive changes in exercise adherence outcomes. Type: Interventional Start Date: May 2022 |
Personalized Therapeutic Neuromodulation for Anhedonic Depression
Stanford University
Treatment Resistant Depression
This study will investigate the anti-anhedonic efficacy of a novel neurostimulation
strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants
with treatment resistant depression (TRD). expand
This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants with treatment resistant depression (TRD). Type: Interventional Start Date: May 2022 |
Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents
University of Texas Southwestern Medical Center
Suicide and Depression
Despite increasing suicide rates in adolescents, there remains a paucity of approaches to
use to prevent re-attempts. Any hope for breaking the code to prevent youth suicide lies
in understanding biological factors that play a role. Evidence suggests that inflammation
and immune system dysfunction... expand
Despite increasing suicide rates in adolescents, there remains a paucity of approaches to use to prevent re-attempts. Any hope for breaking the code to prevent youth suicide lies in understanding biological factors that play a role. Evidence suggests that inflammation and immune system dysfunction may be linked to suicide. The investigators will develop immune profiles for adolescents with suicidal behavior and those at risk in order to develop tools that can be implemented for prevention efforts. This study involves blood draws, answering questions, and completing questionnaires - no treatment or intervention is provided as part of this study. Participants will be screened to see if they qualify for this study using questionnaires. Participants will be teens (ages 12-18 years) with recent suicidal behavior, teens at-risk for developing depression, and healthy control teens. Participants complete all study-related tasks four times over a period of 12 months. Electronic surveys will be sent to participants to complete monthly. Both the adolescent and if applicable, their parent (or legally authorized representatives, LARs), will answer questions regarding depression, anxiety, and suicidal thoughts/behaviors. Type: Observational Start Date: Apr 2021 |
Neural Response to Inflammatory Challenge in Major Depressive Disorder
Laureate Institute for Brain Research, Inc.
Major Depressive Disorder
This is a parallel group, double-blinded, placebo-controlled study. Participants with MDD
(n=90) and HC (n=90) will be randomly assigned (2:1) to receive either lipopolysaccharide
(LPS) (0.8ng/kg of body weight) or placebo (same volume of 0.9% saline) administered as
an intravenous bolus. This will... expand
This is a parallel group, double-blinded, placebo-controlled study. Participants with MDD (n=90) and HC (n=90) will be randomly assigned (2:1) to receive either lipopolysaccharide (LPS) (0.8ng/kg of body weight) or placebo (same volume of 0.9% saline) administered as an intravenous bolus. This will yield the following groups: MDD-LPS (n=60), MDD-Placebo (n=30), HC-LPS (n=60), HC-placebo (n=30). There are three main aims: to identify immune pathways and neural circuits that respond differently to LPS in MDD vs. HC subjects; (2) to test whether the strength of inflammatory changes induced by LPS is associated with degree of change in anhedonic symptoms and neural circuits in the MDD group, and (3) to identify a biotype of MDD that shows a differential immunological and neurophysiological response to LPS. The main outcome variables are symptoms of anhedonia measured with the Snaith-Hamilton Pleasure Scale (SHAPS), cytokines (Il-6, IL-8, IL-10, and TNF), and BOLD signal change in the neural circuitry mediating interoceptive processing, i.e. the insula and cingulate cortex. The exploratory aim is to determine whether the acute inflammatory response to LPS can predict the clinical course of depression over a period of six months. The main outcome of this component of the study is self-reported depressive symptoms assessed with the QIDS-SR. Type: Interventional Start Date: May 2021 |
Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862
Washington University School of Medicine
Coronary Heart Disease
Depression
Depression doubles the risk of death in patients with coronary heart disease (CHD), but
so far, there is insufficient evidence that we can reduce the risk of death by treating
depression. This study will investigate the cardiac risk markers that are associated with
depression symptoms that remain... expand
Depression doubles the risk of death in patients with coronary heart disease (CHD), but so far, there is insufficient evidence that we can reduce the risk of death by treating depression. This study will investigate the cardiac risk markers that are associated with depression symptoms that remain despite treatment, and identify potential targets for their treatment. The results of the study will inform the development of more effective interventions to improve both depression and survival in patients with CHD. Type: Observational Start Date: Dec 2020 |
The Role of Virtual Reality During Regional Anesthesia
Cedars-Sinai Medical Center
Anxiety
Pain
In this study, we will analyze the role of virtual reality in acute pain and anxiety
management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical
Center. expand
In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center. Type: Interventional Start Date: Jan 2020 |
Mechanism of Action of Electroconvulsive Therapy
Massachusetts General Hospital
Unipolar Depression
Bipolar Depression
This is an observational neuroimaging study assessing the effects of ECT on the brains of
patients with unipolar and bipolar depression. expand
This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression. Type: Observational Start Date: Jun 2019 |
Optimizing Exposure Therapy for Anxiety Disorders
University of California, Los Angeles
Social Anxiety Disorder
Panic Disorder
The study will compare the effects that two different approaches of exposure therapy have
on reducing fear and anxiety in individuals with social anxiety disorder or panic
disorder. expand
The study will compare the effects that two different approaches of exposure therapy have on reducing fear and anxiety in individuals with social anxiety disorder or panic disorder. Type: Interventional Start Date: Aug 2015 |
Sublingual Cannabidiol for Anxiety
Staci Gruber, Ph.D.
Anxiety
This is an open-label to double-blind study evaluating the effects of cannabidiol (CBD)
for the treatment of anxiety in adults. Participants will use a sublingual
(under-the-tongue) solution of whole plant-derived CBD or placebo three times daily for
four weeks in addition to their normal treatment... expand
This is an open-label to double-blind study evaluating the effects of cannabidiol (CBD) for the treatment of anxiety in adults. Participants will use a sublingual (under-the-tongue) solution of whole plant-derived CBD or placebo three times daily for four weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. In addition, cognitive function and measures of quality of life, sleep, and general health will be assessed at baseline and the post-treatment final visit. Type: Interventional Start Date: Aug 2018 |
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Laureate Institute for Brain Research, Inc.
Depression
This study aims to determine whether a keto-like supplement relative to placebo results
in functional brain changes during fMRI tasks evaluating positive and negative valence in
individuals with moderate to severe depression. In this double-blind randomized
placebo-controlled trial, 75 individuals... expand
This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours. Type: Interventional Start Date: Jan 2024 |
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