Brexpiprazole in Patients With Acute Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily as tablets and capsules, orally

Brexpiprazole

Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

2-4 mg/day, once daily, tablets, orally

Quetiapine extended release

Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.

Group Type OTHER

Quetiapine extended release

Intervention Type DRUG

400-800 mg/day, once daily, encapsulated tablets, orally

Interventions

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Placebo

Once daily as tablets and capsules, orally

Intervention Type DRUG

Brexpiprazole

2-4 mg/day, once daily, tablets, orally

Intervention Type DRUG

Quetiapine extended release

400-800 mg/day, once daily, encapsulated tablets, orally

Intervention Type DRUG

Other Intervention Names

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Seroquel XL®/XR®

Eligibility Criteria

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Inclusion Criteria

* The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
* The patient is willing to be hospitalised from the Screening Visit through Week 6.
* The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
* The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria

* The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
* The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
* The patient has a history of neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
* The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of brexpiprazole.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No