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

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BI 1358894
• Placebo

How Is the Trial Designed?

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+