Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

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Detailed Description

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This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brexpiprazole

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Interventions

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Brexpiprazole

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
* The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria

* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.
* The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No