A study to test whether taking BI 1358894 for 8 weeks helps adults with post-traumatic stress disorder

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 286

Inclusion Criteria

1. Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding to DSM-5 criteria.
2. Time since index event according to Life Events Checklist /CAPS-5 Criterion A at least 3 months before screening visit.
3. PTSD must be the clinically pre-dominant disorder, as per investigator´s judgement. Other comorbid psychiatric disorders are allowed, unless specifically excluded in the exclusion criteria.
4. A total severity score of = 33 on the PCL-5 at the screening visit.
5. Moderate to severe PTSD confirmed by CAPS-5 range = 30 confirmed at screening visit.
6. Male or female patients, 18 to 65 years of age, both inclusively at the time of informed consent.
7. Women who are of child-bearing potential (WOCBP) must be able and willing to use two methods of contraception which include one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier method.
8. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Corresponding to DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder, brief psychotic disorder or any other psychotic disorder as well as MDD with psychotic features as assessed by the MINI at the time of screening.
2. Any psychiatric or non-psychiatric medical condition likely to negatively impact trial participation as per the judgement of the investigator.
3. Acute stress disorder or significant traumatic event within 3 months prior to the screening visit.
4. Use of stimulant medications within 3 months prior to the screening visit (Attention Deficit Hyperactivity Disorder (ADHD) diagnosis alone is not exclusionary)
5. Severe traumatic brain injury (life-time) or moderate traumatic brain injury within the last 2 years prior to screening visit or 3 months for mild traumatic brain injury, based on the Ohio State University TBI Identification Method Short Form. Or history of traumatic brain injury that would impact ability to complete trial assessments or procedures according to investigator.
6. Current treatment with trauma focused therapy (i.e. CPT, PE, EMDR).
A psychotherapy in type, intensity and/or frequency other than trauma focused therapy is allowed if stable within the last 8 weeks prior to screening and not anticipated to change during the entire course of the trial. Long-term psychotherapy is permitted as long as patients are not in an exposure phase during the trial.
7. Diagnosis of a current moderate or severe alcohol use disorder according to MINI within 3 months prior to screening visit (mild alcohol use disorder (AUD) and patients in early remission = criterion not met for between 3 & 12 months are allowed).
8. Diagnosis of a substance use disorder (non-alcohol) according to MINI within 12 months prior to screening visit. Caffeine and nicotine are allowed.
Further criteria apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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