Clinical trial NCT01944969: Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Official title: Interventional, Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-09-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: From baseline to Week 52
measure: Number of Withdrawals
timeFrame: From baseline to Week 52
Secondary outcomes:
measure: Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
timeFrame: From baseline to Week 52
measure: Change in Depressive Symptoms
timeFrame: From baseline to Week 52
measure: Proportion of Patients in Remission
timeFrame: From baseline to Week 52
measure: Change in Clinical Global Impression
timeFrame: From baseline to Week 52
measure: Change in Health-related Quality of Life
timeFrame: From baseline to Week 52
measure: Change in Health-related Quality of Life
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
city: Orlando
country: United States
facility: US008
state: Florida
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: