A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

Date Added
September 18th, 2024
PRO Number
Pro00138636
Researcher
Thomas Uhde

List of Studies


Keywords
Depression, Mental Health
Summary

This study will assess an adjunctive treatment for major depressive disorder (MDD) called Aticaprant. Adults with MDD that are currently on an antidepressant but continue to experience prominent anhedonia may qualify.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437925428
woodsonm@musc.edu

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

Date Added
August 6th, 2024
PRO Number
Pro00137982
Researcher
Sara Witcraft

List of Studies

Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
Summary

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute biweekly (i.e., once every other week) therapy appointments during pregnancy, and three 30-minute therapy appointments monthly during the first three months after childbirth. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, and will be contacted approximately once a month to conduct a medication count. The total duration of the study is 6 months. Compensation is provided.

Institution
MUSC
Recruitment Contact
Maham Dilawar
843-214-4496
dilawarm@musc.edu

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

Date Added
June 4th, 2024
PRO Number
Pro00135785
Researcher
Ronald Acierno

List of Studies

Keywords
Anxiety, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).

AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).

The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.

This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.

This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure

Date Added
March 5th, 2024
PRO Number
Pro00134707
Researcher
Ronald Acierno

List of Studies

Keywords
Mental Health, Military, Psychiatry
Summary

The purpose of this study is to test the effectiveness of a treatment called Transdiagnostic Behavior Therapy (TBT) for reducing symptoms of adjustment disorder compared to the standard treatment, or treatment as usual (TAU) for adjustment disorder called Moving Forward Problem-Solving Therapy (TAU-PST).

Participants will be randomly selected to receive 10-14 weekly sessions of TBT or TAU-PST with a licensed therapist.

This study is open to Veterans and Active-Duty service personnel in the Ralph H. Johnson VA Health Care System catchment area (including Savannah, Myrtle Beach, Hinesville and Beaufort community-based outpatient clinics).

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

Examining Sex and Gender Differences in Patterns of Cannabis Use Motives and Consequences in a Community Sample of Adults Who Use Cannabis

Date Added
February 2nd, 2024
PRO Number
Pro00134281
Researcher
Kathryn Gex

List of Studies

Keywords
Aging, Mental Health, Substance Use, Women's Health
Summary

The goal of this study is to evaluate sex and gender differences across adulthood (18+) in reasons for using cannabis and the perceived severity of consequences associated with cannabis use. We are also interested in understanding how these reasons for cannabis use and perceived severity of consequences are related to other mental and physical health factors. Interested individuals will first complete a brief screening survey. Based on the results of this screening survey, eligible participants will immediately be invited to complete the survey remotely online via a secure web-link. Participants can expect to complete the survey in 30-45 minutes and will be reimbursed $30 via electronic gift card (e.g., Amazon).

Institution
MUSC
Recruitment Contact
Kathryn Gex
843-792-4904
soltisk@musc.edu

Causes and Consequences of Preschooler's Digital Media Use: The Role of Sleep, Physical Activity, Sedentary Behavior and Social Emotional Health

Date Added
December 15th, 2023
PRO Number
Pro00133829
Researcher
Bridget Armstrong

List of Studies

Keywords
Children's Health, Disease Prevention, Healthy Volunteer Studies, Mental Health, Non-interventional, Pediatrics
Summary

Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.

Institution
USC
Recruitment Contact
Michal Talley
8032501730
BA12@mailbox.sc.edu

Listening to Women and Pregnant and Postpartum People: Qualitative Research with American Indian and Hispanic Women

Date Added
December 1st, 2023
PRO Number
Pro00133257
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Pregnancy, Women's Health
Summary

The purpose of this research study is to gather feedback via focus groups/individual interviews and surveys from American Indian and Hispanic pregnant and postpartum people about 1) mental health and substance use concerns and 2) a text message based mental health and substance use disorder screening, referral and treatment program for pregnant and postpartum people called Listening to Women & Pregnant and Postpartum People (LTWP). By gaining the feedback of American Indian and Hispanic people we hope to improve accessibility and efficacy of this program for these populations. Participation involves one individual interview or focus group (a small group discussion) and surveys.

Institution
MUSC
Recruitment Contact
Tychia Brown
843-872-2439
broty@musc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Controlled, 16-week Study to Evaluate the Efficacy and Safety of a Digital Therapeutic (CT-155) as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants with Experiential Negative Symptoms of Schizophrenia

Date Added
November 29th, 2023
PRO Number
Pro00132018
Researcher
Mark Hamner

List of Studies


Keywords
Complementary Medicine, Mental Health
Summary

The Convoke study is looking for people diagnosed with schizophrenia who are are at least 18 years of age; have a primary diagnosis of schizophrenia; have been on a stable dose of antipsychotic medication for at least 12 weeks
before the study treatment period; and own a smartphone compatible with Android 10 or greater, or iOS 14 or greater. The Convoke Study will look at 2 mobile applications (apps) to see if they can support people with moderate to severe negative schizophrenia symptoms. These apps are investigational prescription digital therapeutics (PDTs) that are downloaded onto your smartphone. This study will see if an app can be part of a schizophrenia treatment plan.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu



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