A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103657
• Other study ID #: 1402-0030
• Secondary ID: 2021-003154-23
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: November 20, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• BI 1358894
BI 1358894
• Placebo
Placebo

Locations

Country	Name	City	State
Croatia	Clincal Hospital Centre Rijeka	Rijeka
Croatia	Polyclinic Neuron	Zagreb
Croatia	Psychiatric Hospital 'Sveti Ivan'	Zagreb
Croatia	Solmed Clinic	Zagreb
Croatia	University Psychiatric Hospital Vrapce	Zagreb
Finland	Eira Medical Centre	Helsinki
Finland	Oulu Mentalcare Oy	Oulu
Finland	Mehiläinen Tampere	Tampere
Germany	Universitätsklinikum Aachen, AöR	Aachen
Germany	Zentralinstitut für seelische Gesundheit	Mannheim
Germany	Klinikum der Universität München - Campus Innenstadt	München
Germany	Universitätsklinikum Tübingen	Tübingen
Israel	The Chaim Sheba Medical Center Tel HaShomer	Tel Hashomer
Mexico	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
Poland	MlynowaMed	Bialystok
Poland	In-Vivo Sp. Z o.o.	Bydgoszcz
Poland	MTZ Clinical Research Powered by Pratia	Warszawa
Sweden	Psykiatri Södra Stockholm	Enskede
Sweden	Psykiatri Affektiva sjukdomar	Gothenburg
Sweden	Psykiatri Sydväst Stockholm	Huddinge/Stockholm
Sweden	Akademiska sjukhuset	Uppsala
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Emory University	Atlanta	Georgia
United States	The University of Texas at Austin	Austin	Texas
United States	Pharmasite Research, Incorporated	Baltimore	Maryland
United States	Insight Clinical Trials	Beachwood	Ohio
United States	Hassman Research Institute	Berlin	New Jersey
United States	NeuroBehavioral Medicine Group	Bloomfield Hills	Michigan
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Center For Emotional Fitness	Cherry Hill	New Jersey
United States	American Medical Research	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	CNS Clinical Research - Coral Springs	Coral Springs	Florida
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Relaro Medical Trials, LLC	Dallas	Texas
United States	Mountain Mind. LLC	Denver	Colorado
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Baylor College of Medicine	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Innovative Clinical Research	Lauderhill	Florida
United States	Woodland International Research Group, Inc.	Little Rock	Arkansas
United States	ASCLEPES Research Centers, P.C. dba Alliance Research	Long Beach	California
United States	CalNeuro Research Group Inc.	Los Angeles	California
United States	Miami Dade Medical Research Institute, LLC	Miami	Florida
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Elixia PHC, LLC	Saint Petersburg	Florida
United States	Salem VA Medical Center	Salem	Virginia
United States	Audie L. Murphy VA Hospital	San Antonio	Texas
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	Sisu BHR, LLC	Springfield	Massachusetts
United States	Collaborative Neuroscience Research, LLC	Torrance	California
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Croatia,  Finland,  Germany,  Israel,  Mexico,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CAPS-5 is a 30-item structured interview. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). Each of the 20 symptom items is rated on a 5-point severity rating scale ranging from 0 (absent) to 4 (extreme/incapacitating) CAPS-5 total symptom severity score is yield by summing individual item scores. The total severity score ranges from 0 to 80 with higher scores indicating higher symptom severity.	At baseline and at week 8
Secondary	Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as =30% CAPS-5 reduction from baseline	CAPS-5 is a 30-item structured interview. In addition to assessing the 20 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-Traumatic Stress Disorder (PTSD) symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). Each of the 20 symptom items is rated on a 5-point severity rating scale ranging from 0 (absent) to 4 (extreme/incapacitating) CAPS-5 total symptom severity score is yield by summing individual item scores. The total severity score ranges from 0 to 80 with higher scores indicating higher symptom severity.	At baseline and at week 8
Secondary	Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Response defined as =50% CAPS-5 reduction from baseline	CAPS-5 is a 30-item structured interview. In addition to assessing the 20 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-Traumatic Stress Disorder (PTSD) symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). Each of the 20 symptom items is rated on a 5-point severity rating scale ranging from 0 (absent) to 4 (extreme/incapacitating) CAPS-5 total symptom severity score is yield by summing individual item scores. The total severity score ranges from 0 to 80 with higher scores indicating higher symptom severity.	At baseline and at week 8
Secondary	Change from baseline on the PTSD Checklist for DSM-5 (PCL-5) total score	The PTSD Checklist for DSM-5 (PCL-5) is a 20-item patient-reported assessment designed to measure the presence and severity of PTSD symptoms. The PCL-5 is intended to assess patient symptoms in the past month. Each item is rated on a fivepoint Likert scale, from 0 (not at all) to 4 (extremely). A total severity score can be yield by summing up individual item scores, and ranges from 0 to 80 with higher scores indicating higher severity.	At baseline and at week 8

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