Atomoxetine in Comorbid ADHD/PTSD: A Pilot, Placebo-Controlled Feasibility Study Save

Date Added
September 1st, 2015
PRO Number
Pro00036485
Researcher
Zhewu Wang
Keywords
ADD/ADHD, Military, Psychiatry, Stress Disorders
Summary

Future Direction: The current available treatments for PTSD are not fully effective for cognitive symptoms of PTSD and have high drop-out and poor engagement, two factors found to be most indicative of overall return to functioning for patients with PTSD. Successful completion of this pilot clinical trial may build a platform for future large scale double-blind, placebo-controlled studies using either atomoxetine or psycho-stimulants or other cognitive enhancing medications. The response inhibition related measurements are sensitive to psychotropic medications. Therefore it is advantageous for us to use GNG and Stop Signal approaches to investigate individual treatments response in our future research. We believe GNG and Stop signal approaches together with pharmacogenetic approach will provide valuable information to direct future individualized medicine.

Institution
MUSC
Recruitment Contact
Howard Mandel
(843) 789-7104
mandelh@musc.edu

Treatment of Prolonged Grief Disorder in Combat Veterans Save

Date Added
September 1st, 2015
PRO Number
Pro00036533
Researcher
Ronald Acierno
Keywords
Anxiety, Depression, Mental Health, Military, Psychiatry
Summary

The 'dual burden' of (a) loss of a fellow service member in the context of (b) experiencing repeated extreme life threat is unique to military combat personnel and a core characteristic of combat-related Prolonged Grief Disorder (PGD), a disorder as prevalent as Post-traumatic stress disorder and associated with functional impairment, disability, and suicidality. Effective treatments for depression and PTSD have proven less than adequate in treating PGD when each is offered in isolation; and simply combining these 12-16 week treatment regimens into a 24-36 week treatments is not a viable approach, particularly with a population predisposed to avoiding extended mental health care. The proposed project addresses the need for a Veteran/ military specific treatment of PGD, and uses technology to deliver this treatment in a format that is far more likely to be accepted by military personnel and Veterans. This study will impact clinical practice by providing the first evidence for effective treatment PGD in Veterans.

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

Augmenting Prolonged Exposure Therapy for PTSD with Intranasal Oxytocin Save

Date Added
September 1st, 2015
PRO Number
Pro00036616
Researcher
Julianne Hellmuth
Keywords
Drug Studies, Healthy Volunteer Studies, Mental Health, Psychiatry, Stress Disorders
Summary

The main goal of current study is to compare changes in PTSD symptoms following Prolonged Exposure therapy (PE) combined with either a 40 IU dose of intranasal oxytocin or placebo. This will allow us to assess the potential benefits of augmenting PE with oxytocin. Prior to 8 of the 10 weekly therapy sessions (sessions 2-9), subjects will receive oxytocin or placebo.

Institution
MUSC
Recruitment Contact
Sudie Back
843-792-9383
backs@musc.edu

Exploring sex differences in the neural correlates of PTSD: Impact of oxytocin Save

Date Added
August 4th, 2015
PRO Number
Pro00019290
Researcher
Margaret Moran-santa maria
Keywords
Brain, Mental Health, Psychiatry
Summary

Although sex differences in brain development, structure and function are well known, few studies have explored how these differences contribute to risk and resilience to mental illness. Therefore, biomedical research studies investigating sex differences in brain physiology may lead to more effective intervention and treatment strategies.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Cortical Excitability: Biomarker and Endophenotype in Combat Related PTSD Save

Date Added
August 4th, 2015
PRO Number
Pro00012134
Researcher
Zhewu Wang
Keywords
Healthy Volunteer Studies, Mental Health, Military, Psychiatry, Stress Disorders
Summary

The objective of the proposed study is to investigate the cortical excitability in combat related PTSD. To accomplish this objective, we will recruit combat veterans with and without PTSD. Clinical assessment will be performed to assess the severity of PTSD and combat exposure. A newly developed transcranial magnetic stimulation approach will be applied to examine the cortical excitability, then genetic analysis will be used to learn how genetic factors influence individual cortical excitability. We expect this innovative approach will enhance our knowledge about the mechnism of PTSD development.

Institution
MUSC
Recruitment Contact
Howard Mandel
843-789-7104
howard.mandel@va.gov

Neuroimaging Mechanisms of Overlap Between Alcoholism and Bipolar Disorder Save

Date Added
August 4th, 2015
PRO Number
Pro00019393
Researcher
James Prisciandaro
Keywords
Alcohol, Mental Health, Psychiatry, Substance Use
Summary

Bipolar disorders (BD) and substance use disorders (SUD) co-occur very frequently, and co-occurring BD and SUD are associated with devastating public health costs. Unfortunately, there has been very little neurobiological research involving individuals with co-occurring BD and SUD to guide the development of effective treatments for this treatment-resistant population. In response to this clinical need, the proposed study will evaluate a potential mechanistic model of BD and alcohol dependence (AD) co-occurrence, involving shared neurochemical and neurobehavioral dysregulations, that could help to identify novel therapeutic targets for individuals with co-occurring BD and AD.

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

An Investigation of Disturbances in Glutamatergic Neurotransmission in Frequent Heavy Episodic Drinkers Save

Date Added
August 4th, 2015
PRO Number
Pro00036435
Researcher
James Prisciandaro
Keywords
Alcohol, Mental Health, Psychiatry, Substance Use
Summary

Heavy episodic drinking (consuming 4+/5+ alcoholic beverages, for women/men respectively, over a relatively brief period of time) disproportionately characterizes young adult alcohol consumption and is a major public health concern. Research in individuals with advanced alcohol dependence has demonstrated neurochemical disturbances (particularly involving the excitatory neurotransmitter, glutamate) that are highly dynamic during early abstinence from alcohol and that are directly implicated in compulsive alcohol use, craving, and risk of relapse. Demonstrating similar disturbances in young, frequent heavy episodic drinkers may provide greater insight into the transition between heavy young adult drinking and later, advanced alcohol dependence that could be used to predict and prevent this transition as well as to develop novel strategies to reduce the negative consequences of problematic drinking in young adults. The present study will repeatedly measure in-vivo concentrations of neurochemicals implicated in alcohol dependence, including glutamate and gamma-Aminobutyric acid, using state of the art two-dimensional proton magnetic resonance spectroscopy in a group of frequent heavy episodic drinkers and a group of light drinker comparators following a discrete period of monitored abstinence from alcohol.

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

A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents Save

Date Added
June 29th, 2015
PRO Number
Pro00026459
Researcher
Mark George
Keywords
Adolescents, Depression, Psychiatry
Summary

This study will provide preliminary information regarding the use of repetitive Transcranial Magnetic Stimulation (rTMS) in a medication-free adolescent population. We will be looking at what effects (good and bad) the rTMS treatment has on adolescent depression.
TMS is FDA approved for adults but there are very little data on its use in adolescents.

Institution
MUSC
Recruitment Contact
Jkeonye Moss
843-876-5141
mosjk@musc.edu

The Better Resiliency Among Veterans with Omega-3?s (BRAVO) study: A Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid Supplementation among Military Veterans Save

Date Added
June 16th, 2015
PRO Number
Pro00024475
Researcher
Bernadette Marriott
Keywords
Alcohol, Depression, Metabolism, Military, Nutrition, Psychiatry
Summary

Suicide is the tenth leading cause of death in the United States with approximately 30,000 civilian deaths annually. Suicide has continued to increase in the military and is particularly high among Veterans. Omega-3 Highly Unsaturated Fatty Acids (HUFAs) are essential for brain function and must be obtained from food. US food production practices over the last century have resulted in a dramatic change in the fatty acid profile of the US diet. At the same time, evidence continues to build regarding the potential importance of omega-3s on emotional state, thinking and mental health. Nearly all US military personnel have low n-3 HUFA status. The purpose of this study is to investigate whether supplementation with omega-3s will reduce the risk for suicidal behaviors, depression, and PTSD in an at-risk population. Sub-analyses will evaluate associated alcohol use disorders and the neurological impact of the omega-3 fatty acid action using functional magnetic resonance imaging. The potential outcome of this study would be information supporting the role of dietary supplements of omega-3 fatty acids contributing to reducing suicide risk and associated mental disorders.

Institution
MUSC
Recruitment Contact
BRAVO call center
888-322-6884
bravo@musc.edu

Group Motivational Interviewing (GMI) for Homeless Veterans in VA Services Save

Date Added
June 8th, 2015
PRO Number
Pro00032504
Researcher
Elizabeth Santa ana
Keywords
Mental Health, Psychiatry
Summary

This is a randomized controlled trial comparing GMI to a control treatment condition (CT) across five critical outcomes. 186 Veterans in VA housing services (93 per treatment arm) will be enrolled with a diagnosis of alcohol or drug abuse/dependence. Recruitment will take place in Charleston VAMC HUD-VASH & GPD. Participants will be randomly assigned to (1) GMI or (2) CT, each consisting of 4 sessions, will attend a booster session at 2 months, and will be evaluated at 1, 3, and 6 months. Participants with a non-substance related DSM-IV-TR major Axis I disorder (e.g., MDD, PTSD) will be eligible for the study. Analyses will be conducted using generalized linear mixed models (GLMM) approach.

Institution
MUSC
Recruitment Contact
Kayla Lamb
(843) 789-7168
lamb@musc.edu

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