Title: A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients with PTSD.

Lead Investigator: Mark S. George, MD, Medical University of South Carolina.

Study Sites: Ralph H. Johnson VA Medical Center (RHJVAMC) and Walter Reed National Military Medical Center (WRNMMC)

Study Purpose: The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with major depressive disorder (MDD), posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or a combination of these.

Participants: Participants will include 60 inpatient veteran volunteers aged 18-70 years old. This research is sponsored by the U.S. Army Medical Research and Materiel Command (USAMRMC).

Title: Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment of OEF/OIF/OND Veterans.

Lead Investigator: Ariel J. Lang, PhD, MPH, University of California, San Diego.

Study Sites: VA San Diego Healthcare System, VAMC Cincinnati, VAMC Durham, VAMC Togus, VA Puget Sound Healthcare System, Walter Reed National Military Medical Center.

Study Purpose: This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present Centered Therapy (PCT). ACT asks individuals to move forward in accordance with one's values regardless of limitations rather than struggling against those limitations. PCT focuses on current life concerns and the relationship between those concerns and symptoms.

Participants: 178 veteran volunteers (18 years or older) with distress and impairment who deployed as part of Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn (OEF/OIF/OND). Volunteers will be recruited across 5 VA sites and 1 military treatment center around the country.

Title: CONcussion Treatment After Combat Trauma (CONTACT): The Effect of Telephone Follow-Up on Outcome for Service Members with Mild TBI/PTSD.

Lead Investigator: Kathleen R. Bell, MD, University of Washington.

Study Site: Madigan Army Medical Center (MAMC) and Womack Army Medical Center (WAMC).

Study Purpose: This study compares the effects of Individualized Scheduled Telephone Support (ISTS) and Usual Care (UC) for active military or national guard/reserve status service members with Mild Traumatic Brain Injury (mTBI). ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g. anxiety, depression) that commonly co-occur with mTBI. UC is the care typically provided to service members attending the Traumatic Brain Injury (TBI) clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period.

Participants: A total of 400 service members (18 years and over) will participate in this study.

Title: Brain Indices of Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury

Lead Investigator: Connie Duncan, PhD National Capital Area Integrated Clinical Study Site.

Study Site: Walter Reed National Military Medical Center (WRNMMC)

Study Purpose: The purpose of this study is to improve our understanding of the relationship between injury and PTSD in service members. By studying brain measures and type of injury, the study hopes to find a way to predict the development of PTSD, general health, and emotional well-being after injury. This may also lead to improvements in treatment.

Participants: A total of 240 service members are expected to take part in this study (120 subjects with mild TBI, as well as 120 subjects with non-TBI injuries from Walter Reed National Military Medical Center and Fort Belvoir Community Hospital).

Title: A Proof of Concept, Double-Blind, Randomized, Placebo-Controlled Study of Ganaxolone in Post-Traumatic Stress Disorder.

Lead Investigator: Christine Marx, MD, MA, Duke University; Ann Rasmusson, MD, Boston University.

Study Sites: Durham VAMC, Washington DC VAMC, Manchester VAMC, White River Junction VAMC, Boston VA Research Institute, Cincinnati VAMC, Ralph H. Johnson VAMC, VA San Diego Health Care System.

Study Purpose: The purpose of the study is to find out what effects, good and/or bad, ganaxolone has on symptoms of PTSD compared to placebo for the treatment of PTSD symptoms. Ganaxolone is an “investigational drug”, which means that it is still being tested in research studies and is not currently approved by the US Food and Drug Administration (FDA).

Participants: Approximately 120 veterans or civilians (18-55 years old) will take part in this study at 8 different centers in the United States.

Title: Cognitive Remediation After Trauma Exposure (CREATE) or Randomized, Controlled Trial of galantamine, methylphenidate, & placebo for treatment of Cognitive Symptoms in Patients with mTBI or PTSD.

Lead Investigator: Thomas W. McAllister, MD, Dartmouth College; Ross Zafonte, DO, Spaulding Rehabilitation Hospital.

Study Sites: Manchester VAMC, White River Junction VAMC, VA San Diego Healthcare System, Spaulding Rehabilitation Hospital, University of Cincinnati, Duke University, Ralph H. Johnson VAMC.

Study Purpose: The purpose of the study is to learn about the effectiveness of two medications (methylphenidate and galantamine) in reducing cognitive symptoms (problems with memory, attention or other thinking process) in participants with PTSD and/or TBI. This study will evaluate the efficacy of methylphenidate (approved for the treatment of attention deficit hyperactivity disorder and narcolepsy) and galantamine (approved to treat mild to moderate dementia) in the treatment of persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or mild traumatic brain injury (mTBI).

Participants: Participants involve individuals (veterans and civilians) with post traumatic stress disorder (PTSD) and/or mild traumatic brain injury (mTBI) ages 18-55 years old.

Title: A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

Lead Investigator: Howard Eisenberg, MD, University of Maryland

Study Sites: University of Maryland, Baltimore and University of California, San Diego

Study Purpose: This research is being done to see if traumatic brain injury (TBI) patients treated with the study drug (glyburide) will show improvement in swelling and bleeding in the brain, as measured by images of the brain taken with MRI and CT scans. This study is also trying to find out if patients with TBI show more improvement than TBI patients with placebo. Finally, the study also aims to find out if the study drug is safe and well tolerated in patients with TBI.

Participants: Participants are individuals, veterans and civilians, (18-70 years old) suffering from traumatic brain injury (TBI).