- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697603
A Study of Brexpiprazole in Patients With Major Depressive Disorder
July 19, 2022 updated by: Otsuka Pharmaceutical Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
740
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Fukushima, Japan
- Nanko-kokorono clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brexpiprazole 1mg
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
|
Tablets, Oral, once daily, 14 weeks
Other Names:
|
Experimental: Brexpiprazole 2mg
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
|
Tablets, Oral, once daily, 14 weeks
Other Names:
|
Placebo Comparator: Placebo
Tablets, Oral, once daily, 14 weeks
|
Tablets, Oral, once daily, 14 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period
Time Frame: Baseline and Week 14
|
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.
|
Baseline and Week 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14
Time Frame: Baseline and 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.
|
Baseline and Week 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2018
Primary Completion (Actual)
June 6, 2022
Study Completion (Actual)
July 4, 2022
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 5, 2018
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 331-102-00058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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