Clinical trial NCT05103657: A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder
Official title: A Phase II, 8-week-treatment, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy, Tolerability and Safety of Orally Administered BI 1358894 in Patients With Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-11-02
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale for DSM-5 (CAPS-5) Total Severity Score at Week 8
timeFrame: 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.
Secondary outcomes:
measure: CAPS-5 Response, Defined as ≥30% CAPS-5 Reduction From Baseline at Week 8
timeFrame: At baseline and at 8 weeks after start of treatment.
measure: CAPS-5 Response, Defined as ≥50% CAPS-5 Reduction From Baseline at Week 8
timeFrame: At baseline and at 8 weeks after start of treatment.
measure: Change From Baseline on the PTSD Checklist for DSM-5 (PCL-5) Total Score at Week 8
timeFrame: 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.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, Inc.
state: Arkansas
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Long Beach
country: United States
facility: ASCLEPES Research Centers, P.C. dba Alliance Research
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group Inc.
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research, LLC
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Denver
country: United States
facility: Mountain Mind. LLC
state: Colorado
city: Coral Springs
country: United States
facility: CNS Clinical Research - Coral Springs
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Elixia PHC, LLC
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: American Medical Research
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Pharmasite Research, Incorporated
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Springfield
country: United States
facility: Sisu BHR, LLC
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: NeuroBehavioral Medicine Group
state: Michigan
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Beachwood
country: United States
facility: Insight Clinical Trials
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials, LLC
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Audie L. Murphy VA Hospital
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Rijeka
country: Croatia
facility: Clincal Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Polyclinic Neuron
city: Zagreb
country: Croatia
facility: Solmed Polyclinic
city: Zagreb
country: Croatia
facility: Psychiatric Hospital 'Sveti Ivan'
city: Zagreb
country: Croatia
facility: University Psychiatric Hospital Vrapce
city: Helsinki
country: Finland
facility: Eira Medical Centre
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy
city: Tampere
country: Finland
facility: Mehiläinen Tampere
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Mannheim
country: Germany
facility: Zentralinstitut für seelische Gesundheit
city: München
country: Germany
facility: Klinikum der Universität München - Campus Innenstadt
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center Tel HaShomer
city: Culiacan
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra
city: Monterrey
country: Mexico
facility: CIT-Neuropsique S.C
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C.
city: Bialystok
country: Poland
facility: MlynowaMed
city: Bydgoszcz
country: Poland
facility: In-Vivo Sp. Z o.o.
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Enskede
country: Sweden
facility: Psykiatri Södra Stockholm
city: Gothenburg
country: Sweden
facility: Psykiatri Affektiva sjukdomar
city: Huddinge/Stockholm
country: Sweden
facility: Psykiatri Sydväst Stockholm
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
References: