A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD) Save

Date Added
June 27th, 2017
PRO Number
Pro00064375
Researcher
Mark George
Keywords
Depression, Military, Psychiatry, Stress Disorders
Summary

Objectives: The aim of the study is to evaluate the efficacy and safety of DTMS for the treatment of PTSD.
Patient Population: 176 male and female subjects, 22-68 years of age, currently diagnosed with PTSD according to the DSM-V criteria.
Structure: A randomized, controlled, prospective, 9 week, double blind, multicenter study.
Blinding: The treatment administrator, study rater, all study personnel and patients will be blinded to the treatment being administered.
Concurrent Control: The study group will receive active DTMS treatment and the control group will receive inactive, sham treatment.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 577 5011 ext 5209
matthew.schmidt@va.gov

An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment-resistant Depression Save

Date Added
May 23rd, 2017
PRO Number
Pro00066401
Researcher
Robert Malcolm
Keywords
Depression, Drug Studies, Mental Health, Psychiatry
Summary

There is an ethical obligation to provide continued intranasal esketamine treatment to subjects who participated in select Phase 3 studies and for whom the benefit versus risk has been favorable. This study provides an opportunity for subjects who have participated in the ESKETINTRD3004 study to continue to receive open label intranasal esketamine until: it is commercially available or a pre-approval access program is made available to the subject in the subject?s respective country; the subject does not benefit from further treatment (based on the investigator?s clinical judgment), the subject withdraws consent; or the company terminates clinical development of intranasal esketamine for Treatment Resistant Depression (TRD).

Institution
MUSC
Recruitment Contact
Kristina Huebner
843-792-1231
huebnerk@musc.edu

Optimization of ECT in the Treatment of Veterans with Co-morbid Major Depression and PTSD Save

Date Added
May 2nd, 2017
PRO Number
Pro00062581
Researcher
Mark George
Keywords
Depression, Military, Psychiatry
Summary

The purpose of this study is to determine if there are any differences in the improvement of MDD and PTSD symptoms when using two different types of ECT, and also to determine what effect recalling two different memories (a positive memory or negative PTSD memory) just prior to receiving ECT may have on PTSD symptoms. The two types of ECT treatment to be used in this study are called right unilateral ultrabrief (RUL UB) ECT and bilateral brief pulse (BL BP) ECT. Both types of ECT are widely used in the treatment of depression and are commonly used when ECT is recommended. This study will involve 70 (35 local and 35 at Long Beach VA site) subjects who are veterans suffering from MDD and PTSD.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843-577-5011 ext 5209
NA

Progesterone for the treatment of cannabis withdrawal Save

Date Added
May 2nd, 2017
PRO Number
Pro00065954
Researcher
Brian Sherman
Keywords
Psychiatry, Substance Use
Summary

The purpose of the study is to explore the effects of progesterone on cannabis withdrawal in women who regularly smoke marijuana. Participants will be asked to abstain from marijuana use for 5 days after the onset of menses. They will receive 8 doses of either progesterone or placebo during this time. On Days 1 and 5 they will come to the clinic to complete study assessments and provide urine, saliva and blood samples.On Days 2-4 assessments will be completed via text messages, Redcap surveys and video calls. Participants will be monitored for adverse events and cannabis withdrawal on each study day.

Institution
MUSC
Recruitment Contact
Lisa Nunn
8437920476
jenkinli@musc.edu

Imaging Framework for Testing GABAergic/glutamatergic Drugs in Bipolar Alcoholics Save

Date Added
April 4th, 2017
PRO Number
Pro00064964
Researcher
James Prisciandaro
Keywords
Alcohol, Depression, Mental Health, Psychiatry, Substance Use
Summary

This study examines the effects of the medication gabapentin and the supplement n-acetylcysteine among individuals with Bipolar Disorder who regularly drink alcohol. Participants in this study will take gabapentin, n-acetylcysteine, and matched placebo (one at a time) for 5 days each. There are 8 study visits, including 3 MRI scans.

Institution
MUSC
Recruitment Contact
Helena Brenner
843-792-0572
brennerh@musc.edu

Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder Save

Date Added
March 7th, 2017
PRO Number
Pro00062819
Researcher
Susan Sonne
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

This study is designed to evaluate the safety and effectiveness of using two different medications (extended release naltrexone and bupropion) compared to matching placebo (an inactive substance) in the treatment of methamphetamine use disorder. Participants will receive study medications along with brief medication management for twelve weeks, with follow up visits at weeks 13 and 16.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
864-898-5800
echapman@bhspickens.com

A Preliminary Investigation of Pre-Frontal repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder. Save

Date Added
January 3rd, 2017
PRO Number
Pro00062407
Researcher
Gregory Sahlem
Keywords
Mental Health, Psychiatry
Summary

Recent research suggests that a new kind of treatment repetitive transcranial magnetic stimulation (rTMS) can help people with addictions quit. This study seeks to recruit individuals who are currently heavy cannabis users, who are attempting to quit using cannabis. In addition to having a 50% chance of receiving rTMS, participants will be given a behavioral treatment with known efficacy.

Institution
MUSC
Recruitment Contact
Margaret Caruso
843-792-5215
warnerma@musc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression and Adult Female Subjects with Moderate Postpartum Depression. Save

Date Added
December 13th, 2016
PRO Number
Pro00061434
Researcher
Constance Guille
Keywords
Depression, Drug Studies, Mental Health, Post Partum Depression, Psychiatry, Women's Health
Summary

This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 7-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

Developing brain stimulation as a treatment for pain in opiate dependent individuals: Parametric assessment of 2 evidence-based strategies Save

Date Added
December 6th, 2016
PRO Number
Pro00061328
Researcher
Colleen Hanlon
Keywords
Psychiatry
Summary

PROJECT SUMMARY Chronic use of opiates is a rapidly escalating crisis in the United States, with over 4.3 million Americans dependent on opiate analgesic, an escalating rate of opiate overdose deaths, and a resurgence of intravenous heroin use leading to total societal cost exceeding $55 billion. The struggle to break the addiction cycle is likely due to factors that affect neural circuits that govern craving and cognitive control. There is growing interest in the utilization of prefrontal cortex repetitive transcranial magnetic stimulation (rTMS) as a novel, non-invasive, non-pharmacologic approach to decreasing craving among chronic opiate users. At this early stage of development, however, it is unclear if the best TMS strategy is to (Strategy 1, Aim 1) increase activity in the dorsolateral prefrontal cortex, or (Strategy 2, Aim 2) decrease activity in the ventromedial prefrontal cortex. To parametrically evaluate these two promising treatment strategies, we have developed a three-visit crossover design wherein a cohort of buprenorphine-maintained (as a therapeutic technique to address opiate dependence) opiate dependent individuals will receive interleaved TMS/BOLD imaging and our established MRI-based thermal pain paradigm immediately before and after rTMS. We will also measure subjective pain and opiate craving ratings. The relative efficacy of Strategy 1 vs 2 will directly translate to development of a large clinical trial of rTMS as an innovative, new treatment option for pain in opiate dependent individuals.

Institution
MUSC
Recruitment Contact
Sarah Hamilton
843-792-6402
hamilsar@musc.edu

Developing an integrated exposure-based therapy for co-occurring PTSD and substance use among adolescents: Teen COPE focus groups Save

Date Added
December 6th, 2016
PRO Number
Pro00060455
Researcher
Sudie Back
Keywords
Adolescents, Alcohol, Anxiety, Mental Health, Psychiatry, Substance Use
Summary

This study aims to conduct focus groups with adolescents and parents (30 adolescents and 30 parents) to gather feedback to help design an integrated psychological therapy for co-occurring PTSD and substance use among adolescents (Teen COPE). This information will be used to make revisions to the new Teen COPE Therapist Guide and Patient Workbook.

Institution
MUSC
Recruitment Contact
Emma Barrett
843-792-5594
barrette@musc.edu

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