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.
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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 |
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement...
The University of Texas Health Science Center, Houston
Depression in Old Age
The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week
social engagement program aimed at reducing depression and increasing social engagement
among seniors who are transitioning out of Adult Protective Services (APS) for either
elder abuse or self-neglect. expand
The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of Adult Protective Services (APS) for either elder abuse or self-neglect. Type: Interventional Start Date: Aug 2023 |
Enhanced Coordinated Specialty Care for Early Psychosis
Mclean Hospital
Psychosis
Schizophrenia
Schizoaffective Disorder
Psychosis Nos/Other
Bipolar Disorder
The goal of this clinical trial is to compare engagement in treatment in coordinated
specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis.
The main question it aims to answer is:
• Does the addition of certain elements of care increase the number of visits in
treatment... expand
The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is: • Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either: - Receive care as usual (CSC) or - Receive care as usual (CSC) plus five additional care elements (CSC 2.0): 1. Individual peer support 2. Digital outreach 3. Care coordination 4. Multi-family group therapy 5. Cognitive remediation Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year. Type: Interventional Start Date: Feb 2024 |
A Closed Loop, Doctor to Patient, Mobile Application for Depression in People With Multiple Sclerosis
University of California, San Francisco
Multiple Sclerosis
MS
Depression
The researchers want to find out if an electronic application called MS CATCH can enhance
patients' and doctors' experiences during and in between clinical visits. MS CATCH is a
smartphone-based tool which allows patients to enter their mood related symptoms at
regular intervals, which is then available... expand
The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health. Type: Interventional Start Date: Aug 2023 |
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
NYU Langone Health
Major Depressive Disorder
The primary purpose of this study is to determine whether empagliflozin, a medication in
a class known as sodium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, may reduce
symptoms of depression. Since this medication helps the body make metabolites known as
ketone bodies which can serve as... expand
The primary purpose of this study is to determine whether empagliflozin, a medication in a class known as sodium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, may reduce symptoms of depression. Since this medication helps the body make metabolites known as ketone bodies which can serve as an alternate energy source for the brain, the investigators can also test whether ketone bodies help with depressed mood. Type: Interventional Start Date: Mar 2023 |
Mechanisms of Behavioral Activation (BA)
Emory University
Depression
The investigators will be comparing brain (neural) activation of depressed adolescent
patients before, during and after a course of Behavioral Activation (BA) therapy using
functional magnetic resonance imaging (fMRI). In particular, the project seeks to
determine whether BA targets different neural... expand
The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures. Type: Interventional Start Date: Jan 2023 |
Mindful Waiting Room
University of Utah
Anxiety State
Depressive State
Pain
Nausea
Fatigue
This will be a single-site, five-arm, parallel group randomized control trial involving
patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded
mindfulness practices delivered in the clinic waiting room will be compared with a
5-minute audio-recording about integrative... expand
This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare. A secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain. Type: Interventional Start Date: Sep 2022 |
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Henry Ford Health System
Insomnia
Depression
Nearly half of women develop insomnia during pregnancy, which is associated with
increased risk for developing perinatal depression. The purpose of this research is to
evaluate the implementability and effectiveness of a mindfulness-based therapy for
insomnia relative to cognitive-behavioral therapy... expand
Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression. Type: Interventional Start Date: Feb 2023 |
Using MHealth to Improve Adherence and Reduce Blood Pressure in Individuals with Hypertension and Mood...
Case Western Reserve University
Bipolar Disorder
Non-Adherence, Medication
Hypertension
Major Depressive Disorder
This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized
patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs.
Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD or MDD. This
practical, technology-facilitated intervention... expand
This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD or MDD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up. Type: Interventional Start Date: Mar 2021 |
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
University of Minnesota
Post-Traumatic Stress Disorders
Major Depressive Disorder
Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is
the most common response to trauma; it is associated with poor clinical outcomes and
substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown
to be at much greater suicidal risk... expand
Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk than individuals with only one of these disorders. Ketamine given as repeated infusions has been shown to be effective in rapidly reducing PTSD and MDD symptoms in treatment resistant PTSD+MDD individuals. However, knowledge about the mechanisms underlying comorbid PTSD and MDD remain limited. The purpose of this study is to use repeated ketamine infusions as a probe to validate a model of PTSD+MDD that focuses on neuroanatomy and executive functioning. Type: Interventional Start Date: Sep 2019 |
Dopaminergic Therapy for Anhedonia - 2
Emory University
Anhedonia
Depression
The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new
treatment options for people with depression who have high inflammation and anhedonia.
Seventy male and female participants with depression, between 25-55 years of age, with
higher levels of inflammation and anhedonia... expand
The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks. Type: Interventional Start Date: Nov 2023 |
Amplification of Positivity for Alcohol Use
Laureate Institute for Brain Research, Inc.
Alcohol Use Disorder
Anxiety
Depression
The proposed study consists of two phases. During Phase 1, the investigators will recruit
a small sample of participants to complete a psychosocial intervention termed
Amplification of Positivity (AMP) for individuals experiencing comorbid depression or
anxiety disorders and alcohol use disorder (AMP-A).... expand
The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI). Type: Interventional Start Date: Sep 2023 |
Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression
University of Texas Southwestern Medical Center
Major Depressive Disorder (MDD)
Healthy Adult Volunteer
This is a cross-sectional pilot study designed to establish hot and cold cognitive
functions and underlying neurocircuitry in older adults with MDD. The investigators will
study 60 participants aged 21-80 years old with MDD. All participants will undergo
clinical and neurocognitive assessment, and... expand
This is a cross-sectional pilot study designed to establish hot and cold cognitive functions and underlying neurocircuitry in older adults with MDD. The investigators will study 60 participants aged 21-80 years old with MDD. All participants will undergo clinical and neurocognitive assessment, and Magnetoencephalography (MEG)/Magnetic resonance imaging (MRI) procedures at one time point. The investigators will also enroll 60 demographically matched comparable, never-depressed healthy participants (controls) to establish cognitive benchmarks. Healthy controls will complete clinical and neurocognitive measures at one time point. To attain a balanced sample of adults across the lifespan, the investigators will enroll participants such that each age epoch (e.g., 21-30, 31-40, etc.) has a total of ten subjects (n=10) in both the healthy control cohort and depressed cohort. Type: Observational Start Date: Dec 2023 |
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
University of Texas at Austin
Major Depressive Disorder
Chronic Major Depression, Recurrent
The purpose of the study is to identify brain biomarkers and characteristics that predict
individual responses to treatment of major depression with the antidepressant drug
sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI)
antidepressant. Our central hypothesis... expand
The purpose of the study is to identify brain biomarkers and characteristics that predict individual responses to treatment of major depression with the antidepressant drug sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI) antidepressant. Our central hypothesis is that brain activity and connections jointly measured with functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) will be able to predict an individual's response to sertraline treatment. Type: Interventional Start Date: Sep 2023 |
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Intra-Cellular Therapies, Inc.
Major Depressive Disorder
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group,
fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an
inadequate response to ongoing ADT. expand
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT. Type: Interventional Start Date: May 2023 |
Lifestyle and Cardiometabolic Risk in Post-9/11 Veterans
VA Office of Research and Development
PTSD
Cardiovascular Disease
Metabolic Syndrome
Heart disease and diabetes are leading causes of death and disability in the US,
especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition
that also affects many Veterans. New research suggests that PTSD further increases the
risk of developing heart disease and diabetes.... expand
Heart disease and diabetes are leading causes of death and disability in the US, especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition that also affects many Veterans. New research suggests that PTSD further increases the risk of developing heart disease and diabetes. What causes this increased risk is unknown. However, individuals with PTSD are often less physically active and make more unhealthy dietary choices than individuals without PTSD. Maintaining a physically active lifestyle, staying physically fit, and eating a healthy diet may be important for reducing the PTSD related risk for heart disease, diabetes and disability. The proposed research seeks to assess how important these lifestyle factors are for reducing the risk of heart disease, diabetes and disability in Veterans with and without PTSD. A better understanding of these lifestyle factors and cardiometabolic health in Veterans will help to clarify how lifestyle interventions can best be applied to the prevention and treatment of long-term disability in Veterans. Aim 1: To examine physical activity participation as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, physical activity, cardiometabolic health, and functioning over time in 250 TRACTS participants. H1-1: Total self-report physical activity will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that lower physical activity will increase the detrimental effect of PTSD on cardiometabolic health and functioning. H1-2: physical activity intensity will moderate the effect physical activity has on cardiometabolic health and functioning. Aim 2: To examine diet quality as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, diet quality, cardiometabolic health, and functioning over time in 200 TRACTS participants. H2: Self-report dietary intake will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that a poor diet will increase the detrimental effect of PTSD on cardiometabolic health and functioning. Supplemental Aim: To validate the use of a self-report clinical measure of physical activity against objective measure obtained via accelerometry. Objective measurement of physical activity is not often accessible or feasible for VA providers (e.g., time constraints). It is essential that quick self-report physical activity measures accurately reflect the physical activity of Veterans. This study will compare data from a self-report clinical physical activity measure to objectively measured physical activity/sedentary time (i.e., accelerometry), cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity in 100 post-9/11 Veterans. H1A-1: Self-report and objective measurement of physical activity will be significantly correlated. H1A-2: Both self-report and objectively measured physical activity/sedentary time will be associated with cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity. Type: Observational Start Date: Feb 2022 |
Reducing Suicide Risk in Older Veterans Using Problem Solving Therapy
VA Office of Research and Development
Suicidal Ideation
Depressive Disorder
Anxiety Disorders
Post Traumatic Stress Disorder
Suicide is a national crisis, especially among older Veterans for whom evidence-based
suicide prevention efforts are lacking. This proposal responds to the national priority
to develop and improve interventions for suicide prevention, with a focus on at-risk
older Veterans. The randomized control... expand
Suicide is a national crisis, especially among older Veterans for whom evidence-based suicide prevention efforts are lacking. This proposal responds to the national priority to develop and improve interventions for suicide prevention, with a focus on at-risk older Veterans. The randomized control trial will compare VA usual care, which is suicide safety planning, with brief Problem Solving Therapy and suicide safety planning. This study uses Problem Solving Therapy because it has support from our pilot data and from secondary data analysis from other studies for reducing late life suicide risk. This treatment also has support for alleviating two key risk factors for late life suicide risk, functional disability and executive dysfunction, and thus this study will examine how older Veterans with varying levels of functional disability and executive functioning respond to treatment to inform future targeted implementation. In accordance with national priorities, existing infrastructure in Problem Solving Training could be expanded to support more rapid VA-wide implementation. Type: Interventional Start Date: Jan 2022 |
ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION
Laureate Institute for Brain Research, Inc.
Major Depressive Disorder
This study aims to determine whether treatment of CMV positive (CMV+) individuals with
major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry,
reduces inflammation, and improves depressive behavior and symptoms to a greater extent
than placebo. In this double-blind, randomized... expand
This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry, reduces inflammation, and improves depressive behavior and symptoms to a greater extent than placebo. In this double-blind, randomized placebo-controlled, parallel group trial, 24 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8-week treatment study. Participants will be randomized with a 1-1 ratio to receive 900 milligrams (mg) VGCV or placebo to be taken orally once per day. Participants will complete a 2-hour pre-screen, a baseline blood-draw, clinical evaluation, and MRI scan (visit 2), a clinical evaluation, blood draw, and MRI scan at week 4 (visit 6), and a clinical evaluation, blood draw, and MRI scan at week 8 (visit 10). Weekly telephonic visits to assess depressive symptoms and side effects will held between the in-person assessments. Type: Interventional Start Date: Nov 2021 |
Non-invasive Nerve Stimulation and Sleep
VA Office of Research and Development
PTSD
People often have difficulty sleeping. Reasons are many. But, difficulty falling and
staying asleep are common issues. Sleep difficulties are common in disorders such as Post
Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective
for everyone. Better treatments are... expand
People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved. Type: Interventional Start Date: Jan 2020 |
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