The Efficacy of 90-Minute vs. 60-Minute Sessions of Prolonged Exposure for PTSD: A Randomized Controlled Trial in Active Duty Military Personnel Save

Date Added
October 3rd, 2017
PRO Number
Pro00069686
Researcher
Ronald Acierno
Keywords
Anxiety, Depression, Mental Health, Military, Psychiatry
Summary

The purpose of the study is to examine whether 60-minute sessions of Prolonged Exposure (PE) is as effective as the standard 90-minute sessions in reducing the symptoms of posttraumatic stress disorder (PTSD). PE is a well-researched, very effective individual (one-to-one) therapy that is designed to help people to deal with traumatic events they have suffered in the past, including combat. This study is being conducted at the Charleston VA Medical Center, surrounding Community-Based Outpatient Clinics (CBOCs), and in the community. It will involve approximately 200 active duty participants. This research is funded by the Department of Defense.

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

Gabapentin for Bipolar & Cannabis Use Disorders: Relation to Brain GABA/Glutamate Save

Date Added
September 5th, 2017
PRO Number
Pro00069905
Researcher
James Prisciandaro
Keywords
Depression, Mental Health, Psychiatry, Substance Use
Summary

This study examines the effects of the FDA-approved medication Gabapentin among individuals with Bipolar Disorder who smoke marijuana. Participants in the study will take Gabapentin and matched placebo (one at a time) for 5 days each. There are 5 study visits, including 2 MRI scans.

Institution
MUSC
Recruitment Contact
Brecken Cornely
843-792-0572
bipolardisorder@musc.edu

The Effects of Theta-Burst Stimulation Duration on Human Motor Cortex Excitability Save

Date Added
August 1st, 2017
PRO Number
Pro00068775
Researcher
Colleen Hanlon
Keywords
Psychiatry, Rehabilitation Studies
Summary

The study will use a new method for non-invasively examining the brain called Transcranial Magnetic Stimulation (TMS). TMS involves placing a coil of wire above the scalp and intermittently passing a very powerful current through it. This current produces energy in the form of a magnetic field that passes through the scalp. The magnetic field, in turn, induces a much weaker electrical current in the brain, causing the neurons directly under the coil to activate for a brief period of time. The U.S. Federal Drug Administration has approved TMS as a method for treating depression since 2008. By using TMS, we can evaluate how well your brain is controlling one of your hand or leg muscles. One way to measure this is by recording activity via electrodes on the hand opposite the side of the brain being stimulated. For example we will be stimulating on the left side of the brain and recording from electrodes on your right hand. In this study we are determining the effects of different types of repetitive Transcranial Magnetic Stimulation (rTMS) protocols on hand movement. rTMS means that the magnetic pulses are applied consecutively, and at a specified pace- the frequency. The specific type of rTMS you will receive is called "theta-burst stimulation" (TBS). TBS is characterized by a specific frequency of stimulation.

Institution
MUSC
Recruitment Contact
John Henderson
792-5560
henderjs@musc.edu

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

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

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

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
Brecken Cornely
843-792-0572
cornely@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

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