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

Phase 1

Active, not recruiting

• Conditions: Major Depressive Disorder; MedDRA version: 16.0 Level: LLT Classification code 10025461 Term: Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025469 Term: Major depressive disorder, single episode, severe degree, without mention of psychotic behavior System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025462 Term: Major depressive disorder, recurrent episode, unspecified degree System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025467 Term: Major depressive disorder, single episode, moderate degree System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025457 Term: Major depressive disorder, recurrent episode, mild degree System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10025458 Term: Major depressive disorder, recurrent episode, moderate degree System Organ Class: 100000004873; MedDRA version: 16.0 Level: LLT Classification code 10; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-004169-42-GB
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-08
• Study Completion: 2014-05-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 26

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, 14570A or 14571A, diagnosed according to DSM-IV-TR™.
• The patient agrees to protocol-defined use of effective contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 554
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

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
14570A or 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified