Back to resultsA Study of Brexpiprazole in Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Brexpiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
- Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent)
- Patients 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," and whose current episode has persisted for at least 8 weeks
Exclusion Criteria:
- Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
- 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.
- Patients with a treatment history showing that all antidepressants (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
Sites / Locations
- Nanko-kokorono clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Brexpiprazole 1mg
Brexpiprazole 2mg
Placebo
Arm Description
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Tablets, Oral, once daily, 14 weeks
Outcomes
Primary Outcome Measures
Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period
The MADRS is a clinician-rated scale which evaluates the level of depression. 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.
Secondary Outcome Measures
The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14
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.
Full Information
NCT ID
NCT03697603
First Posted
July 24, 2018
Last Updated
July 19, 2022
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03697603
Brief Title
A Study of Brexpiprazole in Patients With Major Depressive Disorder
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
July 4, 2022 (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
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
740 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexpiprazole 1mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Arm Title
Brexpiprazole 2mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablets, Oral, once daily, 14 weeks
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
REXULTI
Intervention Description
Tablets, Oral, once daily, 14 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, once daily, 14 weeks
Primary Outcome Measure Information:
Title
Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period
Description
The MADRS is a clinician-rated scale which evaluates the level of depression. 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 14
Secondary Outcome Measure Information:
Title
The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14
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 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent)
Patients 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," and whose current episode has persisted for at least 8 weeks
Exclusion Criteria:
Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
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.
Patients with a treatment history showing that all antidepressants (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
Fukushima
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 Study of Brexpiprazole in Patients With Major Depressive Disorder
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