Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
NCT01052077 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 773 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01052077 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01052077?
The interventions under investigation include: Placebo (DRUG), ADT (DRUG), OPC-34712 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01052077?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.