Anxiety & Depression Association of America

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

Type: Interventional

Start Date: Aug 2023

open study

Objective: Preliminary studies show that low intensity focused ultrasound (LIFU), a new type of non invasive brain stimulation (NIBS), may be able to reach deep structures of the brain involved with depression and anxiety, that remain inaccessible using current forms of NIBS with precision. In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms. The primary objectives of this study are to test the safety and tolerability of LIFU, evaluate the feasibility of using LIFU to reduce brain activity, and evaluate the feasibility of simultaneous fMRI-LIFU. If the results of this study are positive, what the investigators learn will serve as a strong foundation for the future development of innovative treatments for a variety of psychiatric disorders. Research Procedures: 25 veterans will be recruited. Visits will take place at the VA Providence Healthcare System. During some visits, healthy and patient participants may undergo clinical and research neuroimaging, neuropsychological testing, complete questionnaires, and participate in clinical/neurological assessments. Healthy veterans will not receive LIFU and will only attend 2 study visits. Patients are expected to attend up to 8 visits over 6 weeks. However, some may require up to 6 extended follow-ups after visits 5 or 8, in which case they would attend a total of 11 or 14 visits over 6 months. Two patient visits will include the LIFU application, following FDA safety guidelines. Patients will be assigned either to an experiment in which LIFU stimulation will be delivered immediately prior to a task or to an experiment in which stimulation will be delivered during the task. Within each experiment, patients will be assigned to first receive either LIFU stimulation to the study target or anatomical control. Study staff, but not participants will know which location is being targeted in case safety concerns arise. Safety assessments will be conducted at follow-up visits. A clinician will be available during LIFU administration /follow-up visits. Assuming no injury or other concerns are present, patients will then repeat this process again, receiving stimulation targeting other brain area not previously selected.

Type: Interventional

Start Date: Sep 2021

open study

This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.

Type: Interventional

Start Date: Dec 2020

open study

Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.

Type: Interventional

Start Date: Jul 2019

open study

This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.

Type: Interventional

Start Date: Nov 2022

open study

The purpose of this research is to use functional magnetic resonance imaging (fMRI) to investigate how the brain forms associations between neutral and negative stimuli. The ultimate goal is to understand the neural systems involved in regulating negative emotional responses to fearful stimuli.

Type: Interventional

Start Date: Jul 2021

open study

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Type: Interventional

Start Date: Dec 2018

open study

This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.

Type: Interventional

Start Date: Feb 2022

open study

- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users - Assess creatine's effect on methamphetamine use - Assess the safety of creatine in male methamphetamine users with depression

Type: Interventional

Start Date: Nov 2015

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 study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin/orphanin FQ peptide and the nociceptin receptor (NOPR).

Type: Interventional

Start Date: Feb 2025

open study

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

This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to provide a relaxing and engaging experience. Completing the VR intervention may be a safe and effective way to improve quality of life, reduce anxiety, enhance focus, and promote healthy living for cancer patients undergoing treatment.

Type: Interventional

Start Date: Oct 2025

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

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

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 pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

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

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

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

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

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Type: Interventional

Start Date: Jan 2025

open study

The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are: - what are the different clinical and psychosocial functioning outcomes between veterans/active-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only - what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group

Type: Interventional

Start Date: Sep 2025

open study

This study will look at: How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment. The goal is to improve personalized care by: Identifying factors that might predict how someone will respond to a second treatment. Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner. The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.

Type: Interventional

Start Date: Oct 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