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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02433353 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

Results From a 24 Week Trial of EMDR Combined With Venlafaxine XR

EMDRVEN
Start date: January 2016
Phase: Phase 4
Study type: Interventional

Approximately 150 active duty service members meeting Diagnostic and Statistical Manual version 5 (DSM-5) criteria for posttraumatic stress disorder (PTSD) and scoring 50 or above on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited. Qualifying participants will be randomized on a 1:1 basis to either the eye movement desensitization reprocessing (EMDR) plus venlafaxine XR group or the EMDR plus placebo group. Protocol will call for participants to complete 12 one-hour EMDR session while taking a venlafaxine XR/placebo dose of 150mg or 225mg for the entire 24 weeks. Both prescribers and therapists will be blinded and CAPS-5 assessments will be completed by an individual not involved in a participant's direct treatment. An unblinded pharmacist will dispense medication or placebo according the instructions of the prescriber and will count remaining tablets to measure compliance. All EMDR sessions will be recorded and will be reviewed by the principal investigator using a fidelity checklist. CAPS-5 will be administered after completion of EMDR and again at 6 months from the date of his/her first therapy session.

NCT ID: NCT02404402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

LED Treatment to Improve Cognition and Promote Recovery in TBI

LED-TBI
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

NCT ID: NCT02402114 Withdrawn - Clinical trials for Post-Traumatic Stress Disorder

Hydrocortisone for Prevention of Post-Traumatic Stress Disorder

HP-PTSD
Start date: February 2, 2015
Phase: N/A
Study type: Interventional

Post-Traumatic Stress Disorder (PTSD) is an acquired psychiatric condition that occurs after exposure to a dangerous or life-threatening event. It is characterized by persistent fear- and stress-related symptoms, such as nightmares, flashbacks, depression, anxiety and guilt. These symptoms can interfere significantly with patients' lives and in some cases can be debilitating. One of the most frequent causes of PTSD is being a victim of a violent, interpersonal assault. PTSD is felt to be primarily a disorder of memory formation - stressful memories are encoded too strongly in a patient's long-term memory, remaining too accessible and "present" to the patient long after the actual threat has passed. In recent years evidence has emerged that it may be possible to prevent PTSD by moderating the process of memory consolidation that occurs in the hours and days after a traumatic event. Early research has suggested that enhancing the body's natural cortisol response to a stressful event may be a safe and effective way of moderating the process of memory consolidation and promoting adaptive, non-pathological memory encoding. In particular, the administration of hydrocortisone, a safe and widely used drug that mimics the body's own cortisol hormone, appears to reduce the risk of developing PTSD in patients who have sustained a traumatic event. However, this research is still in relatively early stages, and requires larger trials to confirm its efficacy. In addition, the research thus far has not adequately targeted assault victims, whom Investigator feel are some of the patients most likely to benefit from such an approach. Investigators propose a prospective, placebo-controlled, double-blinded trial of administering single-dose oral hydrocortisone or placebo to 100 assault victims seen in the Einstein Medical Center Philadelphia Emergency Department to determine if this approach has efficacy in preventing PTSD. This study is designed as a pilot study, with the hopes that the data gathered in it can be used to design a larger and more robust trial in the future.

NCT ID: NCT02400736 Completed - Clinical trials for Major Depressive Disorder

Supported Employment in Patient Aligned Care Teams

Start date: August 3, 2015
Phase: N/A
Study type: Interventional

In response to the Rehabilitation Research and Development (RR&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and re-establish civilian life. This study provides the requisite evidence needed to guide the Veterans Health Administration (VHA) as to whether to expand the target population for IPS to Veterans with any mental disorder, delivered directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA practice could substantially improve Veteran vocational rehabilitation access and outcomes, moving a significantly greater number of disabled Veterans back to full and productive lives in the community.

NCT ID: NCT02398136 Withdrawn - PTSD Clinical Trials

To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD

Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD.

NCT ID: NCT02397889 Completed - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)

Start date: May 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.

NCT ID: NCT02391402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

CABA
Start date: May 4, 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.

NCT ID: NCT02384369 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Trial of Oral SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder

PTSD
Start date: June 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs. Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo.

NCT ID: NCT02382848 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

Start date: July 2015
Phase: N/A
Study type: Interventional

This research is being done to find out how effective Prazosin is in the treatment of bulimic patients experiencing distressing nightmares using subjective and objective measures.

NCT ID: NCT02377089 Completed - Clinical trials for Post-Traumatic Stress Disorder

Neuromodulation for Post-Traumatic Stress Disorder

Start date: May 2014
Phase: N/A
Study type: Interventional

The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS) to examine the efficacy of TNS as a new treatment for Post Traumatic Stress Disorder (PTSD) in veterans. Recruitment will take place at the PTSD Outpatient Clinic at the Veterans Affair Greater Los Angeles (VA GLA). Study participants will be asked to complete, at most, 9 assessments/questionnaires regarding their PTSD symptoms and quality of life, use the TNS device every night for 8 hours, log their use of the device, and attend weekly visits to monitor safety and complete assessments. Each subject will be asked to attend 8 visits over the course of 8 weeks. Subjects who receives the sham-controlled treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to examine symptom improvements. Enrollment and subject-related procedures are projected to take approximately 36 months. Preparations for clinical trial, clinical trial/study procedures and data analysis will occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration of this project is approximately 4 years.