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

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

Extinguishing Fear and Craving: Neuromodulating Shared Circuits Save

Date Added
March 7th, 2017
PRO Number
Pro00064233
Researcher
Lisa Mcteague
Keywords
Alcohol, Anxiety, Brain, Depression
Summary

Individuals with anxiety disorders are approximately twice as likely as the general population to experience alcohol addiction and vice versa. The affinity toward addiction is especially high in the case of posttraumatic stress disorder (PTSD). Animal and human work has suggested that the neurocircuitry largely overlaps in both the expression and extinction of fear and craving. This study involves utilizing one session of non-invasive brain stimulation (repetitive transcranial magnetic stimulation) to enhance extinction learning as measured with functional magnetic resonance imaging, in both healthy individuals and those with PTSD and alcohol addiction. While this is a single session study, the goal of this study is two identify promising new brain targets to be used therapeutically for individuals suffering from PTSD and alcohol addiction.

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

A Prospective Multicenter Double Blind Randomized Controlled Trial to Compare the Efficacy of the H7-Coil to H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects with Major Depression Disorder (MDD) Save

Date Added
February 28th, 2017
PRO Number
Pro00061794
Researcher
Mark George
Keywords
Depression
Summary

The purpose of this study is to compare the antidepressant efficacy of two different coils used to stimulate the brain during rTMS (repetitive TMS), including the evaluation of both the safety and effectiveness of the test article for the H-7 coil. This study compares the H7-coil (which is new and experimental, and not FDA approved at this time) to the H1-Coil (which is FDA approved to treat depression) deep brain rTMS in subjects with Major Depressive Disorder (MDD).

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 876 5142
schmidm@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

Increasing Treatment Seeking Among At-Risk Service Members Returning From Warzones Save

Date Added
July 22nd, 2016
PRO Number
Pro00053847
Researcher
Tracy Stecker
Keywords
Depression, Military
Summary

We propose a randomized controlled clinical trial of 1,200 military service members who are at increased risk for suicide but not currently in behavioral health treatment. We are testing the effectiveness of a brief phone-based intervention aimed at changing military member's perceptions about behavioral health therapy. Participants will complete five interviews over the course of one year to collect information about change in behavioral health symptoms and treatment engagement.

Institution
MUSC
Recruitment Contact
Elizabeth BelBruno
603-646-7049
elizabeth.k.belbruno@dartmouth.edu

Transcranial Magnetic Stimulation for Depressed Adults with Autism Spectrum Disorder Save

Date Added
July 5th, 2016
PRO Number
Pro00056546
Researcher
Mcleod Gwynette
Keywords
Autism, Depression
Summary

This study is for adults, ages 18 to 65, who have been diagnosed with Autism Spectrum Disorder and have symptoms of Major Depressive Disorder. The treatment used will be Transcranial Magnetic Stimulation (TMS), a non-invasive form of brain stimulation that is FDA-approved for treating depression in adults. The investigators aim to treat participants' depressive symptoms and also study the possible positive impact of TMS on Autism symptoms and irritability associated with autism. In addition, the investigators will obtain imaging studies of the participants to learn more about the impact of TMS on the brain's structure and function in adult subjects with Autism. This is an open-label pilot study, meaning that each participant will receive the same treatment and that there is no 'placebo' treatment given for any of the study participants.

Institution
MUSC
Recruitment Contact
Erin Henneberry
843-657-6799
henneber@musc.edu

The benefits of acute aerobic exercise on neuroplastic potential in depression Save

Date Added
April 5th, 2016
PRO Number
Pro00050872
Researcher
Ryan Ross
Keywords
Depression, Exercise, Mental Health, Nervous System
Summary

Aerobic exercise training has positive effects on depression severity and mood in individuals with depression. The effects of single sessions of aerobic exercise may also provide some short-term benefits in depression. It is believed that a reduction in depression severity may be facilitated by changes in the nervous system, however this has yet to be examined. Although aerobic exercise has beneficial effects for those with depression it is unclear as to why this may occur. Therefore the goal of our project is to better understand the effect of a single session of aerobic exercise on the nervous system, physiology, and mood in depression.

Institution
MUSC
Recruitment Contact
Ryan Ross
862-377-8208
rossre@musc.edu

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