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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01944969
• Other study ID #: 14767B
• Secondary ID: 2012-004169-42
• Status: Terminated
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Brexpiprazole
1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients =65) or 1 mg/day (patients 18-64 years)

Locations

Country	Name	City	State
United States	US008	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events	Number of participants with Treatment-Emergent Adverse Events	From baseline to Week 52
Primary	Number of Withdrawals	Number of withdrawals	From baseline to Week 52
Secondary	Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)	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.	From baseline to Week 52
Secondary	Change in Depressive Symptoms	The Montgomery and Aasberg Depression Rating Scale (MADRS) total score	From baseline to Week 52
Secondary	Proportion of Patients in Remission	Based on a pre-specified MADRS total score	From baseline to Week 52
Secondary	Change in Clinical Global Impression	Clinical Global Impression - Severity of illness (CGI-S) score	From baseline to Week 52
Secondary	Change in Health-related Quality of Life	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score	From baseline to Week 52
Secondary	Change in Health-related Quality of Life	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).	Baseline and Week 52

External Links

•   EudraCT (EMA) Result Posting