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A Study of Brexpiprazole in Patients With Major Depressive Disorder

Sponsor
Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03697603
Collaborator
(none)
740
Enrollment
1
Location
3
Arms
47.1
Actual Duration (Months)
15.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 30, 2018
Actual Primary Completion Date :
Jun 6, 2022
Actual Study Completion Date :
Jul 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brexpiprazole 1mg

Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI

Drug: Brexpiprazole
Tablets, Oral, once daily, 14 weeks
Other Names:
  • REXULTI

    		•
    Experimental: Brexpiprazole 2mg

    Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI

    Drug: Brexpiprazole
    Tablets, Oral, once daily, 14 weeks
    Other Names:
  • REXULTI

    		•
    Placebo Comparator: Placebo

    Tablets, Oral, once daily, 14 weeks

    Drug: Placebo
    Tablets, Oral, once daily, 14 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period [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.

    Secondary Outcome Measures

    1. The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanko-kokorono clinic Fukushima Japan

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03697603
    Other Study ID Numbers:
    • 331-102-00058
    First Posted:
    Oct 5, 2018
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major
    Brexpiprazole

    Study Results

    No Results Posted as of Jul 22, 2022