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

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US008

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexpiprazole

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events
Number of participants with Treatment-Emergent Adverse Events
Number of Withdrawals
Number of withdrawals

Secondary Outcome Measures

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.
Change in Depressive Symptoms
The Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Proportion of Patients in Remission
Based on a pre-specified MADRS total score
Change in Clinical Global Impression
Clinical Global Impression - Severity of illness (CGI-S) score
Change in Health-related Quality of Life
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score
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).

Full Information

First Posted
September 13, 2013
Last Updated
September 18, 2018
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01944969
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because the lead-in study (14571A) in elderly was terminated; see Detailed Description.
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brexpiprazole
Arm Type
Experimental
Arm Description
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events
Description
Number of participants with Treatment-Emergent Adverse Events
Time Frame
From baseline to Week 52
Title
Number of Withdrawals
Description
Number of withdrawals
Time Frame
From baseline to Week 52
Secondary Outcome Measure Information:
Title
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Description
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.
Time Frame
From baseline to Week 52
Title
Change in Depressive Symptoms
Description
The Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Time Frame
From baseline to Week 52
Title
Proportion of Patients in Remission
Description
Based on a pre-specified MADRS total score
Time Frame
From baseline to Week 52
Title
Change in Clinical Global Impression
Description
Clinical Global Impression - Severity of illness (CGI-S) score
Time Frame
From baseline to Week 52
Title
Change in Health-related Quality of Life
Description
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score
Time Frame
From baseline to Week 52
Title
Change in Health-related Quality of Life
Description
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).
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US008
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004169-42/results
Description
EudraCT (EMA) Result Posting

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

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