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A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
NCT01500200 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALKS 5461
Study Locations (20)
Florida
- Alkermes Investigational Site — Fort Myers
- Alkermes Investigational Site — Lauderhill
- Alkermes Investigational Site — Leesburg
- Alkermes Investigational Site — North Miami
- Alkermes Investigational Site — St. Petersburg
California
- Alkermes Investigational Site — Oceanside
- Alkermes Investigational Site — Santa Ana
- Alkermes Investigational Site — Torrance
Massachusetts
- Alkermes Investigational Site — Boston
- Alkermes Investigational Site — Haverhill
New York
- Alkermes Investigational Site — Brooklyn
- Alkermes Investigational Site — New York
Ohio
- Alkermes Investigational Site — Canton
- Alkermes Investigational Site — Dayton
Arizona
- Alkermes Investigational Site — Tucson
Georgia
- Alkermes Investigational Site — Atlanta
Illinois
- Alkermes Investigational Site — Hoffman Estates
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500200
The ClinicalTrials.gov registry entry for NCT01500200 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 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 19 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 2 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: NCT01500200 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Massachusetts. 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 NCT01500200 about?
NCT01500200 is a clinical study titled "A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)". This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
What is the current status of trial NCT01500200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2011-12. Estimated completion is 2013-03.
What conditions does trial NCT01500200 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 NCT01500200?
The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01500200?
This trial is sponsored by Alkermes, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01500200 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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