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

Lundbeck

Status and phase: Terminated; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Brexpiprazole 1 mg; Drug: Placebo; Drug: Brexpiprazole 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01837797

14571A

2012-001361-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Brexpiprazole 1 mg

Experimental group

Description:

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.

Treatment:

Drug: Brexpiprazole 1 mg

Brexpiprazole 3 mg

Experimental group

Description:

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.

Treatment:

Drug: Brexpiprazole 3 mg