A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder

Recruiting at 31 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Stimulants

Disqualifiers: Schizophrenia, Bipolar, Psychotic disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

318 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medicine called BI 1358894 to see if it helps people aged 18 to 65 with PTSD. Participants take the medicine regularly for a period of time. The study checks if their symptoms get better and monitors their health.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use stimulant medications within 3 months before the screening visit, and your current psychotherapy must be stable and not trauma-focused.

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) based on standard guidelines.

Did your traumatic event occur more than 3 months ago?

A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit

Exclusion Criteria

Have you taken any stimulants in the past 3 months?

Are you currently taking any stimulants?

You are not involved in any legal process related to the traumatic event

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take BI 1358894 or placebo as tablets every day for 8 weeks

8 weeks

8 visits (in-person), 4 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1358894
• Placebo

Participant Groups

Group I: BI 1358894 125 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+