Study Seeking Patients with Post Traumatic Stress Disorder (PTSD)

  • STATUS
    Recruiting
  • sponsor
    Otsuka
Updated on 8 November 2020

Summary

Study Seeking Patients with Post Traumatic Stress Disorder (PTSD)

Description

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

Details
Clinical Study IdentifierTX148345
SponsorOtsuka
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Male or female age 18 to 65 years
PTSD as the primary psychiatric diagnosis
Onset of PTSD symptoms at least 6 months prior to screening

Exclusion Criteria

Currently 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 >15 years before screening
Initial onset of trauma occurred before age 16
Subjects with PTSD who are considered resistant/refractory to psychotropic treatment by history
Currently receiving Zoloft with adequate dose and duration (> 50 mg/day for a minimum of 8 weeks)
Currently meets criteria for a Major Depressive Episode (ie, currently symptomatic)
Current or recent history (within 6 months prior to the Screening Visit) of an anxiety disorder (i.e. GAD, OCD etc) which was the primary focus of treatment
DSM-5 diagnosis of any other major psychiatric disorder
Current diagnosis or history of substance or alcohol use disorder (excluding nicotine) (DSM-5 criteria) 120 days prior to the Screening Visit
Positive urine drug screen
History of moderate or severe head trauma or other neurological disorders or systemic medical diseases
Experienced a traumatic event within 3 months prior to screening
Suicide attempt or active suicidal ideation in the last 90 days
HIV, AIDS, HEP B or C
Insulin-dependent diabetes mellitus (IDDM) (ie, any subjects using insulin)
Uncontrolled hypertension or symptomatic hypotension; uncontrolled hyper or hypothyroidism
Epilepsy or a history of seizures, except for a single seizure episode
Received brexpiprazole in any prior clinical trial or currently taking commercially available brexpiprazole (Rexulti®)
Participated in a clinical trial within the last 60 days or more than 2 clinical trials within the past year
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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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