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

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms

Date Added
August 9th, 2024
PRO Number
Pro00138340
Researcher
Thomas Uhde

List of Studies


Keywords
Depression, Sleep Disorders
Summary

This Study will assess whether 20 mg of seltorexant compared with placebo as adjunctive therapy to an SSRI/SNRI antidepressant improves depressive symptoms in participants with MDD and insomnia who have had an inadequate response to current SSRI/SNRI antidepressant therapy.

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

Tracking Brain Imaging Changes in Depression over Clinical Accelerated TMS Therapy at the Individual Level

Date Added
August 6th, 2024
PRO Number
Pro00138260
Researcher
Xiaolong Peng

List of Studies


Keywords
Brain, Depression
Summary

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@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

Combining rTMS & aerobic exercise to treat depression and improve post-stroke walking (RESTORATION)

Date Added
July 2nd, 2024
PRO Number
Pro00137804
Researcher
Chris Gregory

List of Studies


Keywords
Depression, Rehabilitation Studies, Stroke Recovery
Summary

We will determine if aerobic exercise (AEx) and/or repetitive transcranial magnetic stimulation (rTMS) are effective in treating symptoms of depression following stroke. This project is based on the idea that depression negatively affects the brain so that it doesn't change in the same way following treatment, the result being less effective recovery. We believe that effective treatment for depression will help improve how the brain in people with depression responds to other types of treatment. That is, effectively treating depression will enable individuals to better recover other forms of function following their stroke.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@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

National Institute of Mental Health (NIMH) / "A Multi-Site, Randomized, Double-Blind Trial Assessing the Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition

Date Added
November 15th, 2023
PRO Number
Pro00130233
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This NIH sponsored research study with an industry collaborator (MAGNUS) is being conducted at up to five study centers throughout the United States. MUSC is the lead site. Up to 100 inpatient participants with a diagnosis of MDD will be enrolled in this double-blind, randomized, study. There are 2 study arms: active SAINT® and sham "fake" SAINT®. Patients will be randomly assigned, like the flip of a coin (50:50 chance), to active or sham SAINT®.

Institution
MUSC
Recruitment Contact
Elisabeth Collins
843 876 9004
collieli@musc.edu

Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder

Date Added
September 5th, 2023
PRO Number
Pro00128763
Researcher
Charles Palmer

List of Studies

Keywords
Depression, Mental Health, Psychiatry
Summary

The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). The initial visit will involve consent and an MRI scan, followed by two more treatment visits over the course of one week. During the first treatment day, participants will receive either focused ultrasound or sham stimulation. On the second treatment day, all participants will receive focused ultrasound. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments. Follow-up assessments will also involve an MRI scan.

Institution
MUSC
Recruitment Contact
Charles Palmer
843-697-9989
palmecha@musc.edu

EEG-fNIRS Controlled TMS Real-time Neural Feedback for Anti-Depressive Treatment

Date Added
July 5th, 2023
PRO Number
Pro00124800
Researcher
Mark George

List of Studies


Keywords
Brain, Depression
Summary

Currently rTMS for treating depression is delivered without knowing whether the TMS pulses are synchronized with the patient's brain rhythms. We will study healthy and depressed adults with TMS inside of the MRI scanner or outside of the MRI scanner using optics, and test whether it matters precisely timing the TMS pulses with EEG.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843-638-7517
hollanbr@musc.edu

Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement

Date Added
May 16th, 2023
PRO Number
Pro00126436
Researcher
Parneet Grewal

List of Studies

Keywords
Depression, Memory Loss, Stroke, Stroke Recovery
Summary

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu



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