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

Phase 3

Terminated

Conditions: Major Depressive Disorder

Interventions: Drug: Brexpiprazole

Registration Number: NCT01944969

Lead Sponsor: H. Lundbeck A/S

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

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

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, 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Withdrawals	From baseline to Week 52	Number of withdrawals
Number of Participants With Treatment-Emergent Adverse Events	From baseline to Week 52	Number of participants with Treatment-Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
Change in Depressive Symptoms	From baseline to Week 52	The Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Change in Clinical Global Impression	From baseline to Week 52	Clinical Global Impression - Severity of illness (CGI-S) score
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)	From baseline to Week 52	The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.
Proportion of Patients in Remission	From baseline to Week 52	Based on a pre-specified MADRS total score
Change in Health-related Quality of Life	Baseline and Week 52	The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).