A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/day) as Monotherapy or as Combination Therapy in the Treatment of Adults with Post-traumatic Stress Disorder

  • STATUS
    Recruiting
  • sponsor
    Otsuka
Updated on 25 March 2021

Summary

A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole (1 - 3 mg/day) as Monotherapy or as Combination Therapy in the Treatment of Adults with Post-traumatic Stress Disorder

Description

Primary: To evaluate the efficacy of brexpiprazole as monotherapy or as combination treatment with Zoloft (sertraline) in adult subjects with PTSD.

Secondary: To evaluate the safety and tolerability of brexpiprazole 1 to 3 mg/day as monotherapy or as combination treatment with Zoloft (sertraline) in adult subjects with PTSD.

Free trial related exams and medications.
Compensation $75 for each completed visit.

Details
Clinical Study IdentifierTX149038
SponsorOtsuka
Last Modified on25 March 2021

Eligibility

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
The subject has a CAPS-5 total score = 33 at Screening and Baseline (Day 0) Visits
Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening
Subjects willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period

Exclusion Criteria

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, OR the subject is engaged in compensation litigation or other processes whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorder
The index traumatic event that led to development of PTSD took place > 15 years before screening
Initial onset of trauma occurred before age 16
Subjects with PTSD who, in the investigator's opinion, are considered resistant/refractory to psychotropic treatment by history
Subjects who are currently receiving Zoloft (sertraline) with adequate dose and duration (> 50 mg/day for a minimum of 8 weeks)
Subjects who have had initiation of, or a change in, psychotherapy, EMDR therapy or any other intervention for the treatment of PTSD symptoms within 28 days prior to the
Screening Visit or it is anticipated that the subject will have a change in psychotherapy, EMDR therapy, or in any other intervention during the trial
Subjects who meet the DSM-5 criteria for a current Major Depressive Episode (ie, currently symptomatic)
Subjects who have current or recent history (within 6 months prior to the Screening Visit) of an anxiety disorder that has been the primary focus of psychiatric treatment including: generalized anxiety disorder, social anxiety disorder, panic disorder, obsessive-compulsive, and other related disorders
Subjects who have a DSM-5 diagnosis of delirium, major neurocognitive, or other cognitive disorder; schizophrenia, schizoaffective disorder, or other psychotic disorder; bipolar I or II disorder, or bipolar disorder not otherwise specified; eating disorder (including anorexia nervosa or bulimia); or borderline or antisocial personality disorders, or intellectual disability
Other criteria applied
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