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

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ClinicalTrials.gov Identifier: NCT02012218
Recruitment Status : Completed
First Posted : December 16, 2013
Results First Posted : October 8, 2015
Last Update Posted : December 29, 2015
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 16, 2013
Results First Submitted Date  ICMJE September 4, 2015
Results First Posted Date  ICMJE October 8, 2015
Last Update Posted Date December 29, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
The change from Baseline to Week 6 in the MADRS total score. [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT02012218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder (MDD)
Intervention  ICMJE
  • Drug: ADT
  • Drug: Brexpiprazole
Study Arms  ICMJE Experimental: ADT and Brexpiprazole
ADT and Brexpiprazole
Interventions:
  • Drug: ADT
  • Drug: Brexpiprazole
Publications * Fava M, Okame T, Matsushima Y, Perry P, Weiller E, Baker RA. Switching from Inadequate Adjunctive or Combination Treatment Options to Brexpiprazole Adjunctive to Antidepressant: An Open-Label Study on the Effects on Depressive Symptoms and Cognitive and Physical Functioning. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):22-30. doi: 10.1093/ijnp/pyw087.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
80
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012218
Other Study ID Numbers  ICMJE 331-13-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Junichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP