A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy with Sertraline in the Treatment of Adults with Posttraumatic Stress Disorder

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 6 April 2021

Summary

Brexpiprazole is a medication being studied as a possible adjunctive treatment for post-traumatic stress disorder (PTSD). The medication was first approved in the United States for the treatment of schizophrenia and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Otsuka is conducting this study to find out about the potential benefits and safety of brexpiprazole which is not currently approved by the US Food and Drug Administration (FDA) for the treatment of PTSD. The use of the drug in this study is considered investigational.

About 733 subjects will be in the study and the study is being done at about 80 research sites in the United States. The total participation time in the study will be up to 17 weeks, including 11 office visits in total and the safety follow up phone visit 3 weeks after study treatment completion.

Description

Sponsor: Otsuka
Indication: Post-traumatic Stress Disorder
Study Drug: Brexpiprazole
Study Phase: 3
  • Screening period – up to 14 days – 1 visit
  • Treatment period – 12 weeks – 9 visits
  • Safety follow up period – 3 weeks – 1 visit
33% brexpiprazole + sertraline - 33% placebo + sertraline - 33% placebo + placebo

Details
Condition Post-Traumatic Stress Disorders
Clinical Study IdentifierTX270572
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on6 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females 18-65 years old who have PTSD
Symptoms present for a minimum of 6 months prior to screening

Exclusion Criteria

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
The index traumatic event took place >9 years before screening
The index traumatic event occurred before the age of 16
Currently experiencing trauma, have ongoing contact with their assailant/abuser, or have ongoing legal matters related to their assault/abuse
Subjects who are currently receiving sertraline with adequate dose and duration (>50mg/day for a minimum of 8 weeks)
Subjects with PTSD who are considered resistant/refractory to psychotropic treatment by history
Initiation of, or change in, psychotherapy or any other intervention for the treatment of PTSD within 28 days of screening or at any time during participation (ex. Equine therapy, yoga, mindfulness, etc.)
Subjects who meet criteria for a current MDE
Current or recent history (within 6 months prior to screening) of an anxiety disorder that has been the primary focus of psychiatric treatment including GAD, social anxiety disorder, OCD, and other related disorder
Subjects with 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; borderline or antisocial personality disorders, or intellectual disability
Current diagnosis or history of substance or alcohol use disorder within the past 120 days of screening
History of moderate or severe head trauma or other neurological disorder or systematic medical diseases
Subjects who have experienced a traumatic event within 3 months of screening
Suicidal behavior during the last year prior to screening
Hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to baseline)
Current clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders such as ischemic heart disease, myocardial infarction, CHF, angioplasty, stenting, or coronary artery bypass surgery, HIV/acquired immunodeficiency syndrome, chronic hep B or C
Diabetes mellitus (IDDM or non-IDDM) unless condition is stable and well-controlled (HbA1c 8<)
Uncontrolled hypertension (DBP>95mmHg) or symptomatic hypotension, or orthostatic hypotension
Epilepsy or a history of seizures, except for a single seizure episode
Subjects who have been exposed to brexpiprazole in any prior clinical trial or has received Rexulti
History of neuroleptic malignant syndrome or serotonin syndrome
Those who have participated in a clinical trial within the last 60 days or more than 2 within the past year
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either psychiatric or physical (ex. infectious disease) illness
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