Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (STEP-D222)
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01052077
First received: January 15, 2010
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: OPC-34712 + ADT Drug: Placebo + ADT |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder. |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Change in a depression rating scale [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in disability scale and Clinical Global Impression scale [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
| Enrollment: | 773 |
| Study Start Date: | March 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase B |
Drug: OPC-34712 + ADT
Tablets, Oral, 1 - 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
Drug: Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
|
| Placebo Comparator: Phase A |
Drug: Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
- The current depressive episode must be equal to or greater than 8 weeks in duration
- Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.
Exclusion Criteria:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
- Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052077
Show 43 Study Locations
Show 43 Study LocationsSponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT01052077 History of Changes |
| Other Study ID Numbers: | 331-09-222 |
| Study First Received: | January 15, 2010 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
OPC-34712 Major Depressive Disorder Adjunctive Treatment |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013