A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.
NCT01339689 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT01339689/
Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders
In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.
NCT01338506 — Alcohol Dependence
Status: Completed
http://inclinicaltrials.com/alcohol-dependence/NCT01338506/
Trigeminal Nerve Stimulation for PTSD and Depression
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population. To accomplish our specific aims, the investigators will test the following specific hypotheses: 1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period. 2. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 3. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
NCT01335217 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT01335217/
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both
1. To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD 2. To determine whether performance on these tasks is linked to pertinent psychiatric outcomes (e.g. history of suicidality), which is associated with compromised executive function and impulsivity. 3. To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.
NCT01334463 — Traumatic Brain Injury
Status: Completed
http://inclinicaltrials.com/traumatic-brain-injury/NCT01334463/
Service Dogs for Veterans With PTSD: A Randomized Clinical Trial
The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.
NCT01329341 — PTSD
Status: Terminated
http://inclinicaltrials.com/ptsd/NCT01329341/
The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.
NCT01325168 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT01325168/
An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD
Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder that develops after an extremely stressful event or events. PTSD is associated with problems falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments that do not involve taking medication have been shown to help improve problems related to sleep and nightmares. However, very few of these treatments address both sleep problems and nightmares at the same time, even though many people suffer from both problems. The purpose of this study is to examine the effectiveness of a combined treatment for sleep problems and nightmares in Veterans suffering from combat-related PTSD that is presented in a group format. The investigators hypothesize that the completion of this treatment will lead to increases in sleep quality and decreases in the frequency and severity of nightmares as measured by standard questionnaires.
NCT01314612 — Insomnia
Status: Enrolling by invitation
http://inclinicaltrials.com/insomnia/NCT01314612/
Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants.
The purpose of the study includes: 1. To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU). 2. To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention. We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention offered to parents of NICU infants can prevent or minimize the development of symptoms of psychological distress in parents, including symptoms of anxiety and depression and posttraumatic stress disorder (PTSD).
NCT01307293 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT01307293/
The Psychophysiology and Neurobiology of PTSD Across the Menstrual Cycle
The purpose of this study is to examine the relationship between trauma and startle. The investigators are also looking at the effect of menstrual phase on this relationship.
NCT01304940 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT01304940/
Group Cognitive Processing Therapy for Combat-related PTSD
The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.
NCT01286415 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT01286415/