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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01052077
The ClinicalTrials.gov registry entry for NCT01052077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 773 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (107% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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