Anxiety & Depression Association of America

The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are: - Do these treatments reduce PTSD symptoms in LGBTQIA+ patients? - Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients? - Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms? - Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community? - Do LGBTQIA+ patients complete these treatments? Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.

Type: Interventional

Start Date: Aug 2024

open study

This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.

Type: Interventional

Start Date: Mar 2024

open study

The objective of this proposal is to determine whether heightened negative affective responsivity (NA-R) to daily stressors is related to blunted nitric oxide (NO)-mediated endothelium-dependent dilation (EDD) in working age adults and the extent to which this association is impacted by major depressive disorder (MDD).

Type: Interventional

Start Date: Jan 2025

open study

The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder

Type: Interventional

Start Date: Mar 2025

open study

The goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the VA for healthcare. The main question this study aims to answer is: How do veterans aged 65+ who are enrolled for care at the VA understand ketamine assisted psychotherapy for depression and for end-of-life distress? Using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story. Few contextual details will be offered about the character. In responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics. The purpose of this exercise is to ascertain the participants attitudes and perceptions regarding ketamine assisted psychotherapy.

Type: Observational

Start Date: Nov 2024

open study

Irritable Bowel Syndrome (IBS) is the most common cause of recurrent abdominal pain in children. IBS is a functional gastrointestinal disorder that is linked to motor and sensory physiology, as well as the central nervous system, that presents as abdominal pain with abnormal defecation patterns. This discomfort leads to emotional stress, decreased quality of life, and anxiety. The study proposes that yoga and mindfulness will decrease anxiety and increase quality of life for patients with IBS. The aim of this study is to measure the impact of a brief, at-home, 6-week twice per week Standardized Yoga & Meditation Program for Stress Reduction program on anxiety, IBS symptoms, and quality of life in children ages 12-21 diagnosed with IBS.

Type: Interventional

Start Date: Dec 2020

open study

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

Type: Interventional

Start Date: Jan 2020

open study

The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention.

Type: Observational

Start Date: Apr 2024

open study

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Type: Interventional

Start Date: Mar 2023

open study

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Type: Observational

Start Date: Jul 2020

open study

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.

Type: Observational

Start Date: Sep 2024

open study

This randomized controlled trial will compare two upper-extremity restraint techniques in patients undergoing elective cesarean delivery under neuraxial anesthesia. Participants will be randomly assigned to either standard forearm restraint placement or wrist-level gripping restraint placement. The study will evaluate whether the position of the restraint affects maternal anxiety during and after cesarean delivery. Anxiety will be measured at several perioperative time points using the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes include pain, patient satisfaction, physiological measures such as heart rate and blood pressure, postpartum distress and mood, and restraint-related safety events. The study aims to determine whether wrist-level gripping restraints may reduce anxiety and improve the patient experience compared with standard forearm restraints.

Type: Interventional

Start Date: Jul 2026

open study

This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.

Type: Interventional

Start Date: Aug 2026

open study

The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: - Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? - What adverse events do participants have when taking ACP-211?

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this study is to assess the clinical correlates of therapeutic precision ketosis in bipolar depression and to evaluate the cardiometabolic correlates associated with therapeutic precision ketosis in bipolar depression.

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD). Shared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).

Type: Interventional

Start Date: May 2025

open study

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Type: Interventional

Start Date: Jun 2025

open study

The study aims to evaluate the impact of a bedside-delivered virtual reality (VR) mindfulness experience on well-being and psychosocial outcomes among hospitalized adult patients compared to standard of care (SOC; no added mindfulness intervention).

Type: Interventional

Start Date: May 2026

open study

In the treatment of Major Depressive Disorder (MDD), ketamine can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as ketamine has been suggested to increase synaptic strength. Although determining how ketamine impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of ketamine. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity to assess synaptic strength following ketamine administration. Ten individuals (aged 25-65) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging prior to and following ketamine infusion. Both clinician-administered and subjective mood measures will be collected. It is predicted that ketamine will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.

Type: Interventional

Start Date: Apr 2026

open study

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

Type: Interventional

Start Date: Nov 2024

open study

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. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States of America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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: Feb 2026

open study

The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include: - Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score. - Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20<0.5), at 6 and 12 months. - Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months.

Type: Interventional

Start Date: Jan 2025

open study

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Type: Interventional

Start Date: May 2025

open study

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.

Type: Interventional

Start Date: Oct 2024

open study

This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

Type: Interventional

Start Date: Sep 2024

open study