Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-05-31

Brief Summary

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To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

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Detailed Description

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Conditions

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Major Depressive Disorder

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily, tablets, orally

Brexpiprazole 1 mg

Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day.

Group Type EXPERIMENTAL

Brexpiprazole 1 mg

Intervention Type DRUG

once daily dose, tablets, orally

Brexpiprazole 3 mg

Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day.

Group Type EXPERIMENTAL

Brexpiprazole 3 mg

Intervention Type DRUG

once daily dose, tablets, orally

Interventions

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Placebo

Once daily, tablets, orally

Intervention Type DRUG

Brexpiprazole 1 mg

once daily dose, tablets, orally

Intervention Type DRUG

Brexpiprazole 3 mg

once daily dose, tablets, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient is an outpatient consulting a psychiatrist.
* The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient had at least one previous MDE before the age of 60 years.
* The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential.

Exclusion Criteria

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
* The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
* The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
* 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 had neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has a neurodegenerative disorder.
* The patient has, at the Screening Visit an abnormal ECG that is, 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 IMP.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No