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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)
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 7, 2021
Primary Completion Date
October 12, 2023
Completion Date
November 20, 2023
Last Updated
November 7, 2024
318
ACTUAL participants
BI 1358894
DRUG
Placebo
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT07447089
NCT06516874
Data Source & Attribution
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