A Phase II, 8-week-treatment, multicenter, randomized, double-blind, 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)

Date Added
January 10th, 2023
PRO Number
Pro00124053
Researcher
Mark Hamner

List of Studies


Keywords
Depression, Drug Studies, Mental Health, Military, Psychiatry, Stage II
Summary

While there are medications for PTSD, they don't treat all the symptoms and only affect the severity of some symptoms instead of reducing symptoms overall. As a result, you may be considering other options for your PTSD.

One option to consider is this clinical research study of an oral investigational drug for adults diagnosed with PTSD. In this study, doctors want to evaluate the safety and effectiveness of the investigational drug and compare it to a placebo, which looks like the investigational drug but contains no active medicine. The investigational drug has been studied in clinical research studies before, but it is not approved to treat PTSD. People with PTSD can only receive the investigational drug in clinical research studies like this one.

The results of this study will provide more information about the
investigational drug and whether it could one day be prescribed to
treat PTSD.

If you are eligible for this study and agree to participate, you will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. You have an equal chance of receiving either study drug (investigational or placebo).

You, the study doctor and the study staff will not know which study drug you are receiving. However, in the event of an emergency, this information can be provided.

You will take your assigned study drug once a day for 8-weeks. You will attend up to 8 study center visits for tests, procedures, interviews, and questionnaires to evaluate your health and PTSD. You will also receive 4 phone or video calls from the study doctor/staff to talk about how you are feeling.

Your total study participation will last approximately 16 weeks, which includes screening for eligibility, study drug dosing, and follow-up.

Institution
MUSC
Recruitment Contact
Katelyn Prowell
478-319-6648
prowell@lcvresearch.org

Novel Application of Skills for Psychological Recovery Following Recent Sexual Assault

Date Added
December 22nd, 2022
PRO Number
Pro00122958
Researcher
Alyssa Rheingold

List of Studies