Clinical trials: PTSD, Post Traumatic Stress Disorder
PTSD
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.
- Trial name
- NCT03282123
- Testing
- Midomafetamine, Manualized therapy
- Where
- 12 sites in United States
- Volunteers
- 38 people
- Sponsor
- Resilient Pharmaceuticals
Posttraumatic Stress Disorder (PTSD)
Cognition and Psychotherapy in PTSD
Posttraumatic stress disorder (PTSD) is prevalent among combat Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT) and prolonged exposure therapy, have been…
- Trial name
- NCT03641924
- Testing
- Cognitive Processing Therapy
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- VA Office of Research and Development
PTSD
Sequenced Treatment Effectiveness for Posttraumatic Stress
Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality.
- Trial name
- STEPS (NCT04597190)
- Testing
- Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor, Written Exposure Therapy
- Where
- 15 sites in United States
- Volunteers
- 700 people
- Sponsor
- University of Washington
PTSD
Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas
Military sexual trauma (MST) is a common duty-related stressor which occurs among one in four female Veterans and is associated with substantial concerns about social isolation and high rates of PTSD.
- Trial name
- CWC (NCT03429166)
- Testing
- Skills Training in Affective and Interpersonal Regulation, Present Centered Therapy
- Where
- 2 sites in United States
- Volunteers
- 204 people
- Sponsor
- VA Office of Research and Development
PTSD, Cardiac Arrest
Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest
The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms…
- Trial name
- AMBET (NCT04596891)
- Testing
- Psychotherapy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Research Foundation for Mental Hygiene, Inc.
PTSD
PTSD Treatment for Incarcerated Men and Women: NIMH
Study examining the feasibility of and psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD).
- Trial name
- NCT05168267
- Testing
- Cognitive Processing Therapy
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of Wisconsin, Madison
PTSD, Hiv
CPT-L to Improve Outcomes for Individuals With HIV and PTSD
This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV…
- Trial name
- NCT05275842
- Testing
- Cognitive Processing Therapy- Lifesteps (CPT-L), Lifesteps
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Medical University of South Carolina
PTSD
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition.
- Trial name
- P202 (NCT02421679)
- Testing
- TNX-102 SL
- Where
- 22 sites in United States
- Volunteers
- 159 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
PTSD
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
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.
- Trial name
- NCT03110575
- Testing
- TNX-102 SL
- Where
- 32 sites in United States
- Volunteers
- 190 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
PTSD
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine.
- Trial name
- RECOVERY (NCT03841773)
- Testing
- TNX-102 SL
- Where
- 30 sites in United States
- Volunteers
- 192 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
PTSD
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label…
- Trial name
- P306 (NCT03508700)
- Testing
- TNX-102 SL 5.6 mg
- Where
- 16 sites in United States
- Volunteers
- 93 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
PTSD
Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.
- Trial name
- NCT04030169
- Testing
- Midomafetamine HCl
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 21 people
- Sponsor
- MAPS Europe B.V.
Suicidal Ideation, Suicide, Attempted
Improving Treatment Outcomes for Suicidal Veterans With PTSD
The efficacy of cognitive processing therapy (CPT) for reducing the symptoms of posttraumatic stress disorder (PTSD) across populations including military personnel and veterans is well supported.
- Conditions
- Suicidal Ideation, Suicide, Attempted, Ptsd
- Trial name
- NCT04690582
- Testing
- Cognitive Processing Therapy (CPT), Crisis Response Plan (CRP), Safety Planning Intervention (SPI)
- Where
- United States
- Volunteers
- 157 people
- Sponsor
- Ohio State University
PTSD
Yoga and Physical Activity for Veterans
Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans, leading to significant physical and mental health morbidity and mortality.
- Trial name
- NCT03509909
- Testing
- Hatha yoga, Supportive physical activity
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- VA Office of Research and Development
Ptsd
Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio.
- Trial name
- NCT05938816
- Testing
- Mindfulness-Based Stress Reduction (MBSR), Health and Wellness Education (HWE)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Oregon Health and Science University
PTSD, Physical Injury
IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems
This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems.
- Trial name
- TSOS 7 Peer (NCT03569878)
- Testing
- Peer-Integrated Multidisciplinary Collaborative Care, Trauma surgery team notification
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- University of Washington
PTSD, Depression
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective…
- Conditions
- PTSD, Depression, Chronic Pain, Alcohol Use Disorder
- Trial name
- SERVE:IMPACT (NCT03615222)
- Where
- 2 sites in United States
- Volunteers
- 377 people
- Sponsor
- VA Office of Research and Development
PTSD
Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD
The current pilot project will evaluate the efficacy of adding Written Exposure Therapy (WET) to a course of repeated IV ketamine infusions in improving PTSD symptoms and maintaining symptom improvement in patients with chronic…
- Trial name
- NCT04889664
- Testing
- Ketamine, Written Exposure Therapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
PTSD, Alcohol Use Disorder
BioWare for AUD and PTSD
This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic…
- Trial name
- NCT05187364
- Testing
- COPE
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Medical University of South Carolina
Asthma, PTSD
Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers
Asthma and post-traumatic stress disorder (PTSD) are the most common conditions in World Trade Center (WTC) rescue and recovery workers.
- Trial name
- NCT04552301
- Testing
- Cognitive Processing Therapy, Psychotherapy, Targeted Asthma Education
- Where
- United States
- Volunteers
- 361 people
- Sponsor
- Icahn School of Medicine at Mount Sinai