Study of Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

  • STATUS
    Recruiting
  • sponsor
    H. Lundbeck A/S
Updated on 23 November 2020

Summary

Study of Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

Description

Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study to evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or sertraline on PTSD symptoms.

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT01987960?term=14865A&rank=1 or segaltrials.com

Details
Clinical Study IdentifierTX140960
SponsorH. Lundbeck A/S
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
The patient has PTSD, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI)
The patient has a pre-defined Clinician-Administered PTSD Scale Part 2 (CAPS-2) total score at Screening and Baseline Visits
The reported duration of the PTSD is at least 3 months

Exclusion Criteria

The index traumatic event that led to development of PTSD took place more than 15 years before screening
The patient has a severe personality disorder that in the investigator's opinion may interfere with the conduct of the study
The patient is at significant suicidal risk
Other inclusion and exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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