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A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Rollover subjects

    1. Outpatients
    2. Subjects who have completed the double-blind period of the double-blind trial and can commence the treatment period of this trial within 28 days from the completionof the double-blind period of the double-blind trial
    3. Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
    4. Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode"

  • New subjects

    1. Outpatients
    2. Male and female patients ≥ 65 years of age (at the time of informed consent)
    3. Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
    4. Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" whose current episode has persisted for at least 8 weeks

Exclusion Criteria:

  • Rollover subjects

    1. Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline
    2. Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
    3. Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial
    4. Subjects who are discovered to not meet the inclusion criteria or to fall under any of the exclusion criteria in the doubleblind trial
    5. Subjects who showed marked noncompliance with the IMP treatment in the double-blind trial (subjects whose IMP compliance rates are < 65% between prescribed visits)

  • New subjects

    1. Sexually active male subjects who will not agree to practice 2different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
    2. Patients with a treatment history showing that all antidepressants (also including those not used for the current major depressive episode) cannot be tolerated
    3. Patients with a history of electroconvulsive therapy

    4. Patients with a diagnosis of any of the following diseases according to DSM-5

      1. Neurocognitive disorders
      2. Schizophrenia spectrum and other psychotic disorders
      3. Bipolar and related disorders
      4. Feeding and eating disorders
      5. Obsessive-compulsive disorder
      6. Panic disorder
      7. Posttraumatic stress disorder

Sites / Locations

  • Nanko-kokorono clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexpiprazole

Arm Description

2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily

Outcomes

Primary Outcome Measures

The frequency of Adverse Events
The incidence of the following events will be summarized: •Adverse events occurring after initiation of Interventional Medicinal Product administration

Secondary Outcome Measures

Mean changes from baseline in Montgomery Åsberg Depression Rating Scale（MADRS) at Week 52.
The proportion of subjects who decrease MADRS total scores more than 50%. Reaction Rate and Remission Rate.The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.
The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) scale at Week 52
The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Mean changes from baseline in Clinical Global Impression-Severity of illness(CGI-S) at Week 52
The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Mean changes from baseline in Hamiliton Depression Rating Scale(HAM-D) item total scores at Week 52
The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition.
Mean changes from baseline in Sheehan Disability Scale (SDS) scores at Week 52
SDS Scale is a patient-rated scale which assesses the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10 and the number of "days lost" and "days unproductive" caused by in the past week.

Full Information

First Posted
July 29, 2018
Last Updated
June 29, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03737474
Brief Title
A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
Official Title
A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
March 17, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.

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
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brexpiprazole
Arm Type
Experimental
Arm Description
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Primary Outcome Measure Information:
Title
The frequency of Adverse Events
Description
The incidence of the following events will be summarized: •Adverse events occurring after initiation of Interventional Medicinal Product administration
Time Frame
From baseline to week 52
Secondary Outcome Measure Information:
Title
Mean changes from baseline in Montgomery Åsberg Depression Rating Scale（MADRS) at Week 52.
Description
The proportion of subjects who decrease MADRS total scores more than 50%. Reaction Rate and Remission Rate.The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.
Time Frame
Baseline and Week 52
Title
The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) scale at Week 52
Description
The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Time Frame
Baseline and Week 52
Title
Mean changes from baseline in Clinical Global Impression-Severity of illness(CGI-S) at Week 52
Description
The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Time Frame
Baseline and Week 52
Title
Mean changes from baseline in Hamiliton Depression Rating Scale(HAM-D) item total scores at Week 52
Description
The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition.
Time Frame
Baseline and Week 52
Title
Mean changes from baseline in Sheehan Disability Scale (SDS) scores at Week 52
Description
SDS Scale is a patient-rated scale which assesses the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10 and the number of "days lost" and "days unproductive" caused by in the past week.
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rollover subjects Outpatients Subjects who have completed the double-blind period of the double-blind trial and can commence the treatment period of this trial within 28 days from the completionof the double-blind period of the double-blind trial Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" New subjects Outpatients Male and female patients ≥ 65 years of age (at the time of informed consent) Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" whose current episode has persisted for at least 8 weeks Exclusion Criteria: Rollover subjects Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide. Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial Subjects who are discovered to not meet the inclusion criteria or to fall under any of the exclusion criteria in the doubleblind trial Subjects who showed marked noncompliance with the IMP treatment in the double-blind trial (subjects whose IMP compliance rates are < 65% between prescribed visits) New subjects Sexually active male subjects who will not agree to practice 2different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide. Patients with a treatment history showing that all antidepressants (also including those not used for the current major depressive episode) cannot be tolerated Patients with a history of electroconvulsive therapy Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Feeding and eating disorders Obsessive-compulsive disorder Panic disorder Posttraumatic stress disorder
Facility Information:
Facility Name
Nanko-kokorono clinic
City
Shirakawa
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Learn more about this trial

A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder

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