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BI 1358894 for Post-Traumatic Stress Disorder

Phase 2

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Did your traumatic event occur more than 3 months ago?

Are you 18 to 65 years of age?

Must not have

Have you taken any stimulants in the past 3 months?

Are you involved in any legal processes related to the traumatic event?

Timeline

Screening 4 weeks

Treatment 8 weeks

Follow Up 4 weeks

Summary

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.

Eligible Conditions

Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 4 weeks2 visits

Treatment ~ 8 weeks5 visits

Follow Up ~ 4 weeks1 visit

Screening ~ 4 weeks

Treatment ~ 8 weeks

Follow Up ~4 weeks

This trial's timeline: 4 weeks for screening, 8 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) total severity score

Secondary study objectives

Change from baseline on the PTSD Checklist for DSM-5 (PCL-5) total score

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as ≥30% CAPS-5 reduction from baseline

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as ≥50% CAPS-5 reduction from baseline