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Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

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. Read our disclaimer for details. Identifier: NCT02012218
Recruitment Status : Completed
First Posted : December 16, 2013
Results First Posted : October 8, 2015
Last Update Posted : December 29, 2015
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding adjunctive drug therapy.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: ADT Drug: Brexpiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-label Exploratory Trial to Evaluate the Efficacy, Safety, and Subject Satisfaction With Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ADT and Brexpiprazole
ADT and Brexpiprazole
Drug: ADT
Drug: Brexpiprazole

Primary Outcome Measures :
  1. Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and Week 6 ]
    The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the "best" rating and 6 being the "worst" rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of MDD
  • In current major depressive episode of ≥ 8 weeks in duration and includes an inadequate response to at least 1 adjunctive treatment.
  • Positive history of at least 1 additional failure to an adequate monotherapy antidepressant treatment.
  • HAM-D17 total score≥ 18
  • Currently receiving SSRI of SNRI with adjunctive treatment for at least 6 weeks before screening.
  • Willing to discontinue use of all prohibited psychotropic medications
  • Historical positive serological results for HIV, hepatitis B/C
  • Able to provide written informed consent prior to the initiation of any protocol-required procedures
  • Subjects who could potentially benefit from adjunctive treatment with Brexpiprazole

Exclusion Criteria:

  • Sexually active women of childbearing potential
  • Male subjects not practicing 2 different methods of birth control
  • Females who are breastfeeding and/or who have a positive pregnancy test result
  • Subjects who have received ECT for the current major depressive episode.
  • Subjects who have had an inadequate response to ECT
  • Current need for involuntary commitment or who have been hospitalized within 4 weeks of screening
  • Current Axis I (DSM-IV-TR)
  • Current Axis II (DSM-IV-TR)
  • Subjects experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode.
  • Subjects receiving new onset psychotherapy.
  • Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4, Item 5, or on any of the 5 C-SSRS Suicidal Behavior Items
  • Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
  • Hypothyroidism or hyperthyroidism
  • Clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
  • Currently treated with insulin for diabetes
  • Uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
  • Known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass surgery
  • Epilepsy or history of seizures
  • Positive drug screen
  • The following laboratory test and ECG results are exclusionary:

    1. Platelets ≤ 75,000/mm3
    2. Hemoglobin ≤ 9 g/dL
    3. Neutrophils, absolute ≤ 1000/mm3
    4. AST > 2 × ULN
    5. ALT > 2 × ULN
    6. CPK > 3 × ULN, unless discussed with and approved by the medical monitor
    7. Creatinine ≥ 2 mg/dL
    8. HbA1c ≥ 7.0%
    9. Abnormal free T4 (Note: Free T4 is measured only if result for TSH is abnormal.)
    10. QTcF ≥ 470 msec for females and ≥ 450 msec for males
  • Treatment with an MAOI or EMSAM within 14 days of the Baseline visit.
  • Use of benzodiazepines and/or hypnotics within 7 days prior to the first dose of IMP
  • Use of oral neuroleptics within 7 days prior or long-acting approved atypical antipsychotics ≤ 1 full cycle plus ½ cycle prior to the first dose of IMP
  • Subjects who would be likely to require prohibited concomitant therapy during the trial.
  • Subjects who previously participated in any prior brexpiprazole trial
  • History of neuroleptic malignant syndrome or serotonin syndrome
  • History of true allergic response to more than one class of medications
  • Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • Subjects who participated in a clinical trial within the last 180 days or who participated in more than 2 clinical trials within the past year.
  • Any subject who, in the opinion of the investigator or medical monitor, should not participate.

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): NCT02012218

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
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Study Director: Junichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT02012218    
Other Study ID Numbers: 331-13-001
First Posted: December 16, 2013    Key Record Dates
Results First Posted: October 8, 2015
Last Update Posted: December 29, 2015
Last Verified: November 2015
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder, Depression
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents