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PTSD clinical trials

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NCT ID: NCT03110575 Terminated - PTSD Clinical Trials

12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

Start date: June 20, 2017
Phase: Phase 3
Study type: Interventional

This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

NCT ID: NCT03092687 Terminated - Schizophrenia Clinical Trials

Procedures for Sample Acquisition and Distribution for The Human Brain Collection Core

Start date: March 21, 2017
Phase:
Study type: Observational

Background: The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from deceased people who may or may not have had psychiatric disorders. The next of kin gives permission for researchers to get the tissues. Researchers want to collect medical details of people whose brains are donated. They also want to use the donated tissue to study brain chemistry and structure. This could lead to better treatments for mental illness. Objective: To create a collection of human brain tissue to learn about the causes and mechanisms of mental disorders. Eligibility: People willing to donate their deceased relative s brain tissue. The deceased person could not have had any of the following: Severe mental retardation Long-lasting seizure disorder Infections that affect the brain Decomposition Brain damage Being on a respirator for more than 12 hours Major sepsis Serious renal or hepatic disease Certain dementias and degenerative diseases Design: Medical Examiner s Offices will screen donors who have recently died. Some others will be screened by hospitals or funeral homes. Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue from the deceased person. The tissue will be frozen for future research. Participants will have a 30-minute phone call. They will answer questions about the deceased person s medical and psychiatric conditions. They will answer questions about the person s use of medicines and drugs. Participants will be contacted by a social worker. They will be asked for permission to access the deceased person s medical records.

NCT ID: NCT03062540 Terminated - PTSD Clinical Trials

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

HONOR
Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

NCT ID: NCT02733614 Terminated - PTSD Clinical Trials

Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Start date: December 2016
Phase: Phase 2
Study type: Interventional

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

NCT ID: NCT02174003 Terminated - Depression Clinical Trials

Whole Body Hyperthermia Registry Study

Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

This protocol will allow for the implementation of a research registry pertaining to Whole Body Hyperthermia (WBH) use in various subject populations. The primary objective of the proposed study is to determine if WBH can have beneficial effects in various subject populations currently experiencing numerous other comorbidities, and the duration of the effect(s). This protocol is intended to become a secondary resort for individual's interested in receiving a Hyperthermia treatment for potential beneficial gain related to symptoms stemming from comorbidities other than depression (i.e. Fibromyalgia, Perimenopausal symptoms, arthritis, etc). Due to the fact that no external research funding has been acquired for this broad application this protocol is intended to charge a fee for cost covering purposes only. The registry trial will not be limited to only include individuals with major depressive disorder, however, this protocol will allow for an expanded use in all populations (while still excluding subjects based on safety parameters). We will monitor subject's physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This registry study will include safety assessments 5 days prior to WBH, the day of WBH and 1 week following WBH.

NCT ID: NCT01987960 Terminated - PTSD Clinical Trials

Brexpiprazole as an Additional Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

Start date: December 2013
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or sertraline on PTSD symptoms.

NCT ID: NCT01512303 Terminated - PTSD Clinical Trials

Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

Start date: April 2012
Phase: N/A
Study type: Interventional

The overarching aim of this proposal is to research whether meditation-based treatments are effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which complementary and alternative (CA) treatments are most effective, and how individual differences predict treatment efficacy.

NCT ID: NCT01408641 Terminated - Clinical trials for Alcohol Use Disorder

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Start date: September 2012
Phase: N/A
Study type: Interventional

Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.

NCT ID: NCT01329341 Terminated - PTSD Clinical Trials

Service Dogs for Veterans With PTSD

Start date: July 1, 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00203385 Terminated - PTSD Clinical Trials

Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

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

The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.