A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01727726
First received: October 31, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.


Condition Intervention Phase
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Drug: Brexpiprazole
Drug: Seroquel XR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Randomization Visit to End of Double-Blind Treatment (18 Weeks) ] [ Designated as safety issue: No ]
    The primary outcome is the change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score


Secondary Outcome Measures:
  • Sheehan Disability Scale (SDS) [ Time Frame: Randomization Visit to End of Double-Blind Treatment (18 Weeks) ] [ Designated as safety issue: No ]
    The secondary outcome is the change in Sheehan Disability Scale (SDS) Mean Score


Estimated Enrollment: 2363
Study Start Date: December 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + ADT
Matching Placebo and assigned ADT
Drug: Placebo
tablet/capsule
Experimental: Brexpiprazole + ADT
Brexpiprazole, flexible dose and assigned ADT
Drug: Brexpiprazole
tablet/capsule
Other Name: OPC-34712
Active Comparator: Seroquel XR + ADT
Seroquel XR, flexible dose and assigned ADT
Drug: Seroquel XR
tablet/capsule

Detailed Description:

This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
  • Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
  • Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

  • Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
  • Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
  • Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
  • Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
  • Subjects currently treated with insulin for diabetes.
  • Subjects with uncontrolled hypertension
  • Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
  • Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
  • Inability to swallow tablets or tolerate oral medication
  • Abnormal laboratory test results, vital signs and ECG results
  • Subjects who previously participated in any prior brexpiprazole clinical trial.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727726

Contacts
Contact: INC Research sm_opdc.ctgov@incresearch.com

  Show 76 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Aleksandar Skuban, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01727726     History of Changes
Other Study ID Numbers: 331-12-282
Study First Received: October 31, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Mental Disorders
Mood Disorders
Psychotic Disorders
Behavioral Symptoms
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014