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.
Verified January 2013 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01727726
First received: October 31, 2012
Last updated: January 18, 2013
Last verified: January 2013
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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:
- Sheejan 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: | 1340 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | November 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727726
Contacts
| Contact: INC Research | sm_opdc.ctgov@incresearch.com |
Locations
| United States, California | |
| Recruiting | |
| Beverly Hills, California, United States | |
| Not yet recruiting | |
| Upland, California, United States | |
| United States, Florida | |
| Recruiting | |
| Coral Gables, Florida, United States | |
| Recruiting | |
| Melbourne, Florida, United States | |
| Recruiting | |
| Oakland Park, Florida, United States | |
| Recruiting | |
| Orange City, Florida, United States | |
| Recruiting | |
| Orlando, Florida, United States | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Belmont, Massachusetts, United States | |
| Recruiting | |
| Boston, Massachusetts, United States | |
| United States, Ohio | |
| Recruiting | |
| Dayton, Ohio, United States | |
| United States, Texas | |
| Recruiting | |
| Dallas, Texas, United States | |
| United States, Utah | |
| Recruiting | |
| Murray, Utah, United States | |
| United States, Virginia | |
| Recruiting | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Recruiting | |
| Kirkland, Washington, United States | |
| Recruiting | |
| Seattle, Washington, United States | |
| Canada, British Columbia | |
| Not yet recruiting | |
| Penticton, British Columbia, Canada | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
| Study Director: | James M Youakim, 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: | January 18, 2013 |
| 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 Mental Disorders Psychotic Disorders Mood Disorders Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms Quetiapine |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013