Clinical trials: Trauma and Stress-related Disorders
Workplace Stress, Mental Health
The Effects of Stress & Irregular Shift Hours on First Responders
First Responders are expected to maintain high-performance levels under extreme conditions. However, constant intense workplace stress, physical work demands, and irregular shift hours are taking a severe toll on frontline…
- Conditions
- Workplace Stress, Mental Health, HRV, EEG
- Trial name
- NCT05659277
- Testing
- Workplace Stress and Irregular shift hours
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Endominance
Posttraumatic Stress Disorder
Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with at least severe PTSD.
- Trial name
- NCT03485287
- Testing
- Midomafetamine HCl, Manualized therapy
- Where
- 2 sites in Canada
- Volunteers
- 4 people
- Sponsor
- Resilient Pharmaceuticals
Post-Traumatic Stress Disorder
A Safety & Efficacy Study With Deep Transcranial Magnetic Stimulation for the Treatment of Post-Traumatic Stress Disorder (PTSD)
The purpose of the present study is to evaluate the safety and efficacy of Brainsway Deep TMS (DTMS) for the treatment of PTSD.
- Trial name
- NCT02479906
- Testing
- Deep TMS System
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 203 people
- Sponsor
- Brainsway
PTSD
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
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.
- Trial name
- HONOR (NCT03062540)
- Testing
- TNX-102 SL
- Where
- 44 sites in United States
- Volunteers
- 358 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
PTSD, Mental Illness
Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder
The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).
- Trial name
- NCT07499440
- Testing
- HB-1
- Where
- 16 sites in Australia
- Volunteers
- 200 people
- Sponsor
- HB BioTech, LLC
PostTraumatic Stress Disorder, Sleep Disorder
NightWare Open Enrollment Study
This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress…
- Conditions
- PostTraumatic Stress Disorder, Sleep Disorder, Stress Disorder, Sleep Initiation and Maintenance Disorders
- Trial name
- NWOES (NCT03828656)
- Testing
- NightWare Therapeutic System
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- NightWare
PTSD
Ganaxolone in Posttraumatic Stress Disorder (PTSD)
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).
- Trial name
- NCT01339689
- Testing
- Ganaxolone
- Where
- 8 sites in United States
- Volunteers
- 112 people
- Sponsor
- Marinus Pharmaceuticals
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.
- Conditions
- Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia
- Trial name
- NCT07072728
- Testing
- Psilocybin therapy
- Where
- 5 sites in Australia
- Volunteers
- 87 people
- Sponsor
- Psyence Australia Pty Ltd
Stress Disorders, Post-Traumatic
Trial to Evaluate Efficacy of Magnetic Resonant Therapy (MRT) in PTSD
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
- Trial name
- NCT02268084
- Testing
- Magnetic EEG/ECG-guided Resonance Therapy
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Wave Neuroscience
Stress Disorders, Post-Traumatic, Combat Disorders
NightWare Randomized Trial 02
This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with…
- Conditions
- Stress Disorders, Post-Traumatic, Combat Disorders, Ptsd, Nightmare
- Trial name
- TNT/NW (NCT04040387)
- Testing
- NightWare Therapeutic System
- Where
- 4 sites in United States
- Volunteers
- 270 people
- Sponsor
- NightWare
Post-traumatic Stress Disorder, PTSD
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
- Trial name
- NCT01987960
- Testing
- Brexpiprazole
- Where
- 59 sites in United States, Estonia and 7 more
- Volunteers
- 417 people
- Sponsor
- H. Lundbeck A/S
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
Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy.
- Trial name
- MPLONG (NCT05066282)
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 186 people
- Sponsor
- Resilient Pharmaceuticals
Trauma, Psychological, Social Skills
The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs
There has been substantial progress in developing evidence-based prevention programs (EBPPs) for preventing risky behaviors and promoting positive outcomes for youth.
- Conditions
- Trauma, Psychological, Social Skills, Family Dysfunctional
- Trial name
- Impact (NCT03622138)
- Testing
- Impact
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- 3-C Institute for Social Development
Post Traumatic Stress Disorder
An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD. Participants will be followed for up to 52 weeks.
- Trial name
- IMPACT-EXT (NCT06237426)
- Testing
- Methylone
- Where
- 9 sites in United States, Ireland and 1 more
- Volunteers
- 44 people
- Sponsor
- Transcend Therapeutics
Grief, Post Traumatic Stress Disorder
Walk With Me (WWM) for Perinatal Grief
The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss.
- Conditions
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage
- Trial name
- PeriGrief-II (NCT07011940)
- Testing
- Along With Me, Peer Guide
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Post Traumatic Stress Disorder
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
This is a clinical study for adult subjects with Post Traumatic Stress Disorder.
- Trial name
- NCT01492699
- Testing
- PRX-03140
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Alachua Government Services, Inc.
Posttraumatic Stress Disorder
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD.
- Trial name
- NCT04077437
- Testing
- Therapy, Midomafetamine
- Where
- 14 sites in United States, Israel
- Volunteers
- 121 people
- Sponsor
- Resilient Pharmaceuticals
PTSD - Post Traumatic Stress Disorder
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to…
- Trial name
- NCT07280065
- Testing
- Senseye Diagnostic Tool (DT), Clinician Administered PTSD Scale for DSM-5, Revised Version
- Where
- 6 sites in United States, Australia
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- Senseye, Inc.
Adults, Acute Stress Reaction
Impact of MetaCalm on Stress of Healthy People With Acute Stress
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
- Trial name
- NCT07507669
- Testing
- 2 chewable tablets of MetaCalm, 4 chewable tablets of MetaCalm
- Where
- Italy
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Metagenics, Inc.