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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT00680524 Completed - Clinical trials for Post-Traumatic Stress Disorder

Telephone-based Care for OEF/OIF Veterans With PTSD

Start date: September 2008
Phase: N/A
Study type: Interventional

Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD. Research Plan: This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.

NCT ID: NCT00676182 Completed - Clinical trials for Traumatic Brain Injury

Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury

Start date: July 2008
Phase: N/A
Study type: Observational

The scientific objective of this program is to meet the rehabilitation needs of combat wounded Veterans with mild to moderate Traumatic Brain Injury (TBI) via telerehabilitation and determine the effect of this modality of care on patients' physical health and outcomes including function and community participation. The investigators will also evaluate the benefits and limitations of rehabilitation using telehealth from the Veteran and caregiver perspectives and evaluate the impact of rehabilitation via telehealth on Veterans Administration (VA) healthcare facility use.

NCT ID: NCT00674570 Completed - Clinical trials for Stress Disorders, Posttraumatic

Veteran Stress and Learning Study

VSL
Start date: January 13, 2009
Phase: Phase 4
Study type: Interventional

This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.

NCT ID: NCT00672776 Completed - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a major public health problem in this country. It is estimated that at least one out of every seven women in our society have been the victim of childhood sexual abuse at least once before their 18th birthday. Previous studies have shown that stress is associated with damage to neurons of the hippocampus, a brain area involved in learning and memory. Also, imaging studies of brain function are consistent with dysfunction of the medial prefrontal cortex during presentation of traumatic cues. We have previously shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory function and hippocampal structure in PTSD. We now propose to perform a placebo controlled study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought as paroxetine with less side-effects. The main purpose of this study is to determine the effects of Paxil CR on memory deficits measured with neuropsychological testing, hippocampal volume measured with a magnetic resonance imaging (MRI), medial prefrontal lobe cortical function estimated with PET, and cortisol response (reflecting the intensity of stress) in men and women with PTSD. We plan to recruit 40 subjects. After completing physical examination and evaluating neuropsychiatric history, patients will undergo an initial group of tests which includes memory testing, MRI and PET brain scan, and measurement of cortisol in their saliva. Afterwards, half will receive Paxil CR 12.5 to 62.5 mg and half will receive a placebo (sugar pill) in the beginning of the first 12 weeks as "Double Blind Phase". After 12 weeks, they will be administered memory tests, PET and MRI scan for the post-treatment phase. After this period, Paxil CR will be offered to the placebo group and followed for an additional 12 weeks. They will have final memory tests, and a MRI scan. We hypothesize that Paxil CR exerts its efficacy by acting on abnormal neural circuits, including hippocampus and prefrontal cortex, in PTSD.

NCT ID: NCT00671489 Completed - Trauma Clinical Trials

Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study

Start date: May 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.

NCT ID: NCT00671450 Completed - Clinical trials for Post-Traumatic Stress Disorder

Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study

VDMTBI
Start date: October 2008
Phase: N/A
Study type: Observational

In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of binocular vision problems (such as double/blurry vision, reading difficult, etc.). These individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI. This will provide us with information useful in determining the specific cause of the visual symptoms in the MTBI population.

NCT ID: NCT00671099 Completed - Trauma Clinical Trials

Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

Start date: December 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.

NCT ID: NCT00669981 Completed - Clinical trials for Post-traumatic Stress Disorder

Effectiveness of Cognitive Behavioral Couples Therapy for Post-traumatic Stress Disorder

Start date: August 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.

NCT ID: NCT00659230 Completed - Clinical trials for Posttraumatic Stress Disorder

Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans

Nepicastat
Start date: July 1, 2009
Phase: Phase 2
Study type: Interventional

This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic stress disorder (PTSD) in outpatients who have previously served in a combat zone during Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF)or other Southwest conditions since 19800. A DBH inhibitor's mechanism of action is to decrease neuronal noradrenaline (NA) release by inhibiting DBH conversion of dopamine (DA) to NA. Animal models of PTSD and human studies have found a substantial increase in NA activity for these animal models and for PTSD in humans. Furthermore, recent clinical studies have improved PTSD hyper-arousal symptoms by reducing the NA over-activity using agents like NA post-synaptic antagonists. Key support for the proposed study is based on a similar improvement in PTSD symptoms after treatment with the DBH inhibitor, disulfiram. In the experience of the clinical investigators, the most common chief complaint of the OIF/OEF veterans with PTSD is hyperarousal (DSM-IV criterion D symptom cluster). These symptoms significantly interfere with social, occupational, and interpersonal function. Standard treatments with antidepressants are not fully effective in treating the symptoms of PTSD in veterans; thus, new treatments are needed. An intervention, such as nepicastat, aimed at reducing hyperarousal, as well as other PTSD symptoms, would have significant impact of restoring overall function and quality of life in OIF/OEF veterans with PTSD. Since hyperarousal symptoms responded relatively quickly to medications of this type, our study in 120 outpatient veterans with PTSD will compare nepicastat 120 mg/day vs. placebo in a 6-week double-blind, randomized clinical trial (RCT). The veterans will be followed for an additional 8 weeks after the RCT, during which, those who have a priori defined positive clinical response to the study medication, nepicastat vs. placebo, will be continued on the study medication, in order to assess further improvement and safety. Those patients who do not have a positive clinical response during the 6 week RCT will be offered the addition of the standard first-line PTSD pharmacotherapy, paroxetine, during the 8 weeks extension phase. Thus, weeks 7-14 offer an opportunity to evaluate longer-term nepicastat efficacy and to compare the treatment response of nonresponders after augmentation with paroxetine.

NCT ID: NCT00656344 Completed - Clinical trials for Posttraumatic Stress Disorder

Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Start date: October 2006
Phase: N/A
Study type: Interventional

This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.