A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
NCT ID: NCT05103657
Last Updated: 2024-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2021-12-07
2023-11-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 1358894 125 mg
BI 1358894
BI 1358894
Placebo
Placebo
Placebo
Interventions
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BI 1358894
BI 1358894
Placebo
Placebo
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group, Inc.
Little Rock, Arkansas, United States
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
St. 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
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
Solmed Polyclinic
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
Klinikum der Universität München - Campus Innenstadt
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
The Chaim Sheba Medical Center Tel HaShomer
Tel Litwinsky, , Israel
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, , Mexico
Hospital Aranda de la Parra
León, , Mexico
CIT-Neuropsique S.C
Monterrey, , Mexico
BIND Investigaciones S.C.
San Luis Potosí City, , Mexico
MlynowaMed
Bialystok, , Poland
In-Vivo Sp. Z o.o.
Bydgoszcz, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Psykiatri Södra Stockholm
Enskede, , Sweden
Psykiatri Affektiva sjukdomar
Gothenburg, , Sweden
Psykiatri Sydväst Stockholm
Huddinge/Stockholm, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2021-003154-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1402-0030
Identifier Type: -
Identifier Source: org_study_id
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