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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Brexpiprazole

Criteria

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.