A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
- Registration Number
- NCT05103657
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- Established diagnosis of Post-Traumatic Stress Disorder (PTSD) corresponding to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- Time since index event according to Life Events Checklist / Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Criterion A at least 3 months before screening visit
- 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
- A total severity score of ≥ 33 on the PTSD Checklist for DSM-5 (PCL-5) at the screening visit
- Moderate to severe PTSD confirmed by CAPS-5 range ≥ 30 confirmed at screening visit
- Male or female patients, 18 to 65 years of age, both inclusively at the time of informed consent
- Women who are of child-bearing potential (WOCBP) must be able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier method
- Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- 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 Major Depressive Disorder (MDD) with psychotic features as assessed by the Mini-International Neuropsychiatric Interview (MINI) at the time of screening
- Any psychiatric or non-psychiatric medical condition likely to negatively impact trial participation as per the judgement of the investigator
- Acute stress disorder or significant traumatic event within 3 months prior to the screening visit
- Use of stimulant medications within 3 months prior to the screening visit (Attention Deficit Hyperactivity Disorder (ADHD) diagnosis alone is not exclusionary)
- 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 Traumatic Brain Injury (TBI) Identification Method Short Form. Or history of traumatic brain injury that would impact ability to complete trial assessments or procedures according to investigator.
- Current treatment with trauma focused therapy (i.e. Cognitive Processing Therapy (CPT), Prolonged Exposure Therapy (PE), Eye Movement Desensitization and Reprocessing (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.
- 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) Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1358894 125 mg BI 1358894 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8 The MMRM model is a longitudinal analysis and it incorporated CAPS-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. CAPS-5 is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity. Least Squares (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.
- Secondary Outcome Measures
Name Time Method CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8 At baseline and at 8 weeks after start of treatment. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity.
Number of participants with ≥30% CAPS-5 reduction from baseline at Week 8 is reported.CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8 At baseline and at 8 weeks after start of treatment. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) is a 30-item clinician-administered structured interview that can be used to, make current (past month) diagnosis of PTSD and assess PTSD symptoms over the past week. Each of the 20 symptom items in the CAPS-5 is rated from 0 (absent) to 4 (extreme/incapacitating) with a single severity score combining information about frequency/amount and intensity which is yield by summing each item scores and ranges from 0 to 80 with higher scores indicating higher symptom severity.
Number of participants with ≥50% CAPS-5 reduction from baseline at Week 8 is reported.Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8 The MMRM model is a longitudinal analysis and it incorporated PCL-5 measurements from baseline, Week 4, and Week 8. MMRM estimates of change from baseline to Week 8 is reported. The PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) is a 20-item patient-reported assessment designed to measure the presence and severity of PTSD symptoms in the past month. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. Each item is rated on a five point Likert scale, from 0 (not at all) to 4 (extremely) yielding a total score from 0-80 with higher scores indicating higher severity of the symptoms.
Least Square (LS) means and confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.
Trial Locations
- Locations (61)
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
ASCLEPES Research Centers, P.C. dba Alliance Research
🇺🇸Long Beach, California, United States
CalNeuro Research Group Inc.
🇺🇸Los Angeles, California, United States
Artemis Institute for Clinical Research
🇺🇸Riverside, California, United States
Artemis Institute for Clinical Research, LLC
🇺🇸San Diego, California, United States
Clinical Innovations Inc.
🇺🇸Santa Ana, California, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Torrance, California, United States
Mountain Mind. LLC
🇺🇸Denver, Colorado, United States
CNS Clinical Research - Coral Springs
🇺🇸Coral Springs, Florida, United States
Innovative Clinical Research
🇺🇸Lauderhill, Florida, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Elixia PHC, LLC
🇺🇸Saint Petersburg, Florida, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
American Medical Research
🇺🇸Chicago, Illinois, United States
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
The Chaim Sheba Medical Center Tel HaShomer
🇮🇱Tel Hashomer, Israel
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
🇲🇽Culiacan, Mexico
Hospital Aranda de la Parra
🇲🇽Leon, Mexico
CIT-Neuropsique S.C
🇲🇽Monterrey, Mexico
BIND Investigaciones S.C.
🇲🇽San Luis Potosi, Mexico
MlynowaMed
🇵🇱Bialystok, Poland
In-Vivo Sp. Z o.o.
🇵🇱Bydgoszcz, Poland
MTZ Clinical Research Powered by Pratia
🇵🇱Warszawa, Poland
Psykiatri Södra Stockholm
🇸🇪Enskede, Sweden
Psykiatri Affektiva sjukdomar
🇸🇪Gothenburg, Sweden
Psykiatri Sydväst Stockholm
🇸🇪Huddinge/Stockholm, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Woodland International Research Group, Inc.
🇺🇸Little Rock, Arkansas, United States
Solmed Polyclinic
🇭🇷Zagreb, Croatia
University of Chicago
🇺🇸Chicago, Illinois, United States
Pharmasite Research, Incorporated
🇺🇸Baltimore, Maryland, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Sisu BHR, LLC
🇺🇸Springfield, Massachusetts, United States
NeuroBehavioral Medicine Group
🇺🇸Bloomfield Hills, Michigan, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Center For Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Insight Clinical Trials
🇺🇸Beachwood, Ohio, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
The University of Texas at Austin
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Audie L. Murphy VA Hospital
🇺🇸San Antonio, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Salem VA Medical Center
🇺🇸Salem, Virginia, United States
Clincal Hospital Centre Rijeka
🇭🇷Rijeka, Croatia
Polyclinic Neuron
🇭🇷Zagreb, Croatia
Psychiatric Hospital 'Sveti Ivan'
🇭🇷Zagreb, Croatia
University Psychiatric Hospital Vrapce
🇭🇷Zagreb, Croatia
Eira Medical Centre
🇫🇮Helsinki, Finland
Oulu Mentalcare Oy
🇫🇮Oulu, Finland
Mehiläinen Tampere
🇫🇮Tampere, Finland
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany