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A Study of Brexpiprazole in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03697603
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : August 31, 2020
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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
Major Depressive Disorder Drug: Brexpiprazole Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 : July 30, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

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 Name: REXULTI

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

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

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 [ 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.

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 [ 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03697603

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Contact: Drug Information Center +81-3-6361-7314

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Nanko-kokorono clinic Recruiting
Fukushima, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT03697603    
Other Study ID Numbers: 331-102-00058
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents