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

Lundbeck

Status and phase: Terminated; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944969

2012-004169-42 (EudraCT Number)

14767B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Brexpiprazole

Experimental group

Description:

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

Treatment:

Drug: Brexpiprazole