Anxiety & Depression Association of America

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

Type: Interventional

Start Date: May 2023

open study

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

Type: Interventional

Start Date: Jun 2024

open study

Despite experiencing higher rates of depressive symptoms (Center for Disease Control and Prevention, 2020) and similar rates of Major Depressive Disorder (MDD; Substance Abuse and Mental Health Services Administration (SAMHSA), 2019), Latino adolescents in the U.S. are significantly less likely than their non-Latino White peers to receive treatment for MDD (SAMHSA, 2019). The purpose of this study is to identify a stakeholder-preferred implementation strategy that may improve psychotherapy attendance among Latino adolescents. Latino adolescent-parent dyads and healthcare providers will be recruited from healthcare settings and social media. Focus groups will be conducted with healthcare providers (n=5), and individual interviews will be conducted with Latino adolescents with a diagnosis of depression (n=15) and their parents (n=15).

Type: Observational

Start Date: Oct 2022

open study

Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress. Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits.

Type: Interventional

Start Date: May 2024

open study

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

Type: Interventional

Start Date: Mar 2024

open study

Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.

Type: Interventional

Start Date: Oct 2022

open study

The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, ~50% each) in order to enroll n=320 (B1 and B2) into the RCT.

Type: Interventional

Start Date: Mar 2022

open study

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).

Type: Interventional

Start Date: Apr 2022

open study

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. Each session will be conducted on HIPAA-compliant Zoom and led by the PI (Dr. Gold).

Type: Interventional

Start Date: Dec 2024

open study

This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional magnetic resonance imaging (MRI) and electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.

Type: Interventional

Start Date: Aug 2024

open study

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

Type: Interventional

Start Date: Feb 2022

open study

This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.

Type: Interventional

Start Date: May 2023

open study

This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.

Type: Interventional

Start Date: May 2024

open study

The purpose of this study is to develop and examine a culturally adapted, mobile health application for the Android and iOS platform. The application uses a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Black hazardous drinkers with clinical anxiety.

Type: Interventional

Start Date: May 2023

open study

Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.

Type: Interventional

Start Date: Mar 2026

open study

Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.

Type: Interventional

Start Date: Jan 2026

open study

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: - Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. - Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. - Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

Type: Interventional

Start Date: Feb 2026

open study

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive 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 placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. 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: Dec 2025

open study

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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: Sep 2025

open study

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: - Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? - Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.

Type: Interventional

Start Date: Jan 2026

open study

The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.

Type: Observational

Start Date: Jan 2023

open study

The goal of this clinical trial is to examine the neural mechanisms underlying transcranial magnetic stimulation (TMS) using concurrent functional magnetic resonance imaging (fMRI) in both healthy controls (HCs) and patients with high negative affect symptoms, such as depression. Approximately half male and half female participants aged 18-65 will be recruited. The main questions it aims to answer are: 1. Is the acute/transient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS (rTMS)? 2. Do any of these effects predict negative affect symptoms, such as depression? Participants will: 1. Complete several tests to assess their cognitive abilities and emotional states 2. Undergo several brain scans, including resting-state fMRI, structural MRI, diffusion tensor imaging (DTI), and task fMRI 3. Have two different types of TMS sequences, single-pulse and repetitive pulses, administered to specific brain regions while undergoing fMRI

Type: Interventional

Start Date: Apr 2024

open study

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Type: Interventional

Start Date: Oct 2024

open study

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).

Type: Interventional

Start Date: Dec 2023

open study

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

open study