Anxiety & Depression Association of America

This study is intended to help develop new MRI imaging techniques for studying mood and anxiety disorders. Researchers believe that depression and anxiety disorders may cause structural and functional changes in the brain. This study will optimize the way MRI scans are collected to look at brain structure and examine how the brain behaves while subjects perform particular tasks. Healthy volunteers and individuals with major depressive disorder may be eligible for this study. Participants undergo magnetic resonance imaging (MRI) and neuropsychological testing. : Individuals will be asked to participate in an MRI study on one of several scanners. The scanner used will measure blood flow in the brain, concentrations of certain chemicals in the brain, or magnetic properties of the brain. The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds. Participants may be asked to return for additional scans. The study also involves neuropsychological tests, which assess cognitive performance. Often, people with mood disorders have subtle changes in performance on these tests that allow researchers to pinpoint where brain abnormalities occur. Before the tests can be used in patients, they must be validated by using healthy subjects. These tests are presented either orally, in written form, or on a computer.

Type: Observational

Start Date: Dec 2006

open study

Evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD).

Type: Interventional

Start Date: Oct 2025

open study

By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to: - See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful - See if sending text message prompts between sessions encourages more completion of between-session homework

Type: Interventional

Start Date: Oct 2025

open study

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Type: Interventional

Start Date: Oct 2025

open study

Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma symptoms (PMATS). There is a deficit in resources and access to mental health treatment for pregnant patients, with some treatments being cost-prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to trauma. The investigators developed a low-cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. To revise the implementation plan and intervention (CARE: Communication, Agency, Readiness, Empowerment for cesarean delivery [CD]) for use in large L&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Before initiating such a trial, work needs to be done to modify the intervention and implementation through a process of iterative refinement to enhance the acceptability, appropriateness, and feasibility of implementation in L&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, and hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a steering council. Following this refinement process, a treatment development pilot RCT at a large L&D unit will assess the efficacy of CARE for CD by probing engagement with the target mechanism, as well as assess the feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council.

Type: Interventional

Start Date: Oct 2025

open study

NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.

Type: Interventional

Start Date: Jun 2025

open study

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period

Type: Interventional

Start Date: Sep 2024

open study

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Type: Interventional

Start Date: Feb 2023

open study

Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.

Type: Interventional

Start Date: Sep 2023

open study

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.

Type: Interventional

Start Date: Jun 2022

open study

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Type: Interventional

Start Date: Jun 2022

open study

This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.

Type: Interventional

Start Date: Oct 2022

open study

The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.

Type: Observational

Start Date: Mar 2019

open study

Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: - Brain MRI. Participants will lie on a table in a scanner. - Questions about their medical history and psychology symptoms - Tests of mood and thinking - Tests of brain activity. Participants may do tasks during these tests: - A cone with magnetic detectors is put on the head. - A cap with electrodes is put on the scalp. - TMS. A brief electrical current passes through a wire coil on the scalp. - A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. - There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. - Participants will receive rTMS and another therapy by computer. - For rTMS, repeated pulses will pass through the coil. - This is followed by up to 3 additional visits, when: - Participants will repeat Phase 1 tests - Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.

Type: Interventional

Start Date: May 2018

open study

This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).

Type: Interventional

Start Date: Sep 2025

open study

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in the Mission community for Latino patients with depression and/or anxiety. 213 participants will be enrolled in a one-armed trial comparing self-guided vs. supported dCBT (SilverCloud).

Type: Interventional

Start Date: Aug 2025

open study

The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby. The next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.

Type: Observational

Start Date: Sep 2025

open study

This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.

Type: Interventional

Start Date: Sep 2025

open study

Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby. One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone. This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is: What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression? Participants will - Take a screening questionnaire - Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features. - Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview

Type: Interventional

Start Date: Apr 2025

open study

This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.

Type: Interventional

Start Date: Aug 2025

open study

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be 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: Apr 2025

open study

This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.

Type: Interventional

Start Date: Oct 2025

open study

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Type: Interventional

Start Date: Oct 2024

open study

The goal of this study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.

Type: Interventional

Start Date: Feb 2025

open study