A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
Public ClinicalTrials.gov record NCT05103657. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, 8-week-treatment, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy, Tolerability and Safety of Orally Administered BI 1358894 in Patients With Post-Traumatic Stress Disorder (PTSD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT05103657
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 318 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 7, 2021 (Actual)
- Primary completion
- Oct 12, 2023 (Actual)
- Completion
- Nov 20, 2023 (Actual)
- Last update posted
- Nov 7, 2024
2021 – 2023
United States locations
- U.S. sites
- 37
- U.S. states
- 14
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | — |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California | 90807 | — |
| CalNeuro Research Group Inc. | Los Angeles | California | 90025 | — |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | — |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | — |
| Clinical Innovations Inc. | Santa Ana | California | 92705 | — |
| California Neuroscience Research | Sherman Oaks | California | 91403 | — |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90504 | — |
| Mountain Mind. LLC | Denver | Colorado | 80202 | — |
| CNS Clinical Research - Coral Springs | Coral Springs | Florida | 33067 | — |
| Innovative Clinical Research | Lauderhill | Florida | 33319 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Elixia PHC, LLC | St. Petersburg | Florida | 33713 | — |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30022 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| American Medical Research | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Pharmasite Research, Incorporated | Baltimore | Maryland | 21208 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | — |
| Sisu BHR, LLC | Springfield | Massachusetts | 01103 | — |
| NeuroBehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Insight Clinical Trials | Beachwood | Ohio | 44122 | — |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| The University of Texas at Austin | Austin | Texas | 78712 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Salem VA Medical Center | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05103657, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 7, 2024 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05103657 live on ClinicalTrials.gov.