Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

  • End date
    Jan 23, 2024
  • participants needed
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 4 October 2022


This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult subjects with Post-Traumatic Stress Disorder.

Condition Post Traumatic Stress Disorder
Treatment Placebo, Sertraline, Brexpiprazole
Clinical Study IdentifierNCT04124614
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent
Subjects who have PTSD, diagnosed according to DSM-5, and confirmed by the Mini International Neuropsychiatric Interview (MINI)
Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening

Exclusion Criteria

The index traumatic event that led to the develop of PTSD took place > 9 years before screening
The index traumatic event occurred before age 16
Subjects who have experienced a traumatic event within 3 months of screening
Subjects who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note