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NCT01052077 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 773
- Enrollment target
- 20
- Study locations
NCT01052077: Completed Phase 2 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01052077 is a Phase 2 study of Major Depressive Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 773 participants, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01052077, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 773 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale 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 were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the me
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ADT
- DRUG OPC-34712
Study Locations (20)
California
- Pacific Clinical Research Medical Group - Arcadia
- Southwestern Research - Beverly Hills
- Excell Research - Oceanside
- Affiliated Research Institute - San Diego
- Neuropsychiatric Research Center of Orange County - Santa Ana
- California Neuroscience Research Medical Group, Inc. - Sherman Oaks
Florida
- CNS Clinical Research Group - Coral Springs
- Gulfcoast Clinical Research Center - Fort Myers
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Scientific Clinical Research, Inc. - North Miami
- Clinical Neuroscience Solutions, Inc. - Orlando
Georgia
- Comprehensive NeuroScience, Inc. - Atlanta
- Carman Research - Smyrna
Maryland
- Clinical InSights - Glen Burnie
- Pharmasite Research, Inc. - Pikesville
Alabama
- University of Alabama at Birmingham - Birmingham
Indiana
- Goldpoint Clinical Research, LLC - Indianapolis
Kansas
- Vince and Associates Clinical Research - Overland Park
Michigan
- MSU/Institute for Health Studies - East Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 773 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01052077 record still lists
NCT01052077 is an interventional study that assigns participants to a tested intervention. The registered 773 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (107% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01052077 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01052077 about?
NCT01052077 is a clinical study titled "Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder". 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...
What is the current status of trial NCT01052077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 773 participants. The study started on 2010-03. Estimated completion is 2011-11.
What conditions does trial NCT01052077 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01052077?
The interventions under investigation include: Placebo (DRUG), ADT (DRUG), OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01052077?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01052077 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01052077's enrollment target sits among peer trials
773 14th of 282 higher than 269 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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