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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
NCT02116361 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
Conditions Studied
Interventions
- DRUG Normal Saline
- BIOLOGICAL onabotulinumtoxinA
Study Locations (20)
California
- CITrials — Bellflower
- Radiant Research/Comprehensive Clinical Development, Inc. — Cerritos
- Collaborative Neuroscience Network Inc. — Garden Grove
- Behavioral Research Specialists, LLC — Glendale
- Excell Research, Inc. — Oceanside
- NRC Research Institute — Orange
- Artemis Institute for Clinical Research — San Diego
- Schuster Medical Research Institute — Sherman Oaks
Florida
- Sarkis Clinical Trials — Gainesville
- Clinical Neuroscience Solutions, Inc. — Jacksonville
- Compass Research LLC-North Clinic — Leesburg
- Research Centers of America, LLC — Oakland Park
- Clinical Neuroscience Solutions, Inc — Orlando
- Compass Research, LLC — Orlando
- Stedman Clinical Trials — Tampa
Georgia
- Institute for Advanced Medical Research — Alpharetta
- Atlanta Center for Medical Research — Atlanta
- iResearch Atlanta, LLC — Decatur
Alaska
- Woodland International Research Group — Little Rock
Illinois
- Uptown Research Institute, LLC — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2014-04-22 |
| Est. Completion | 2016-12-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02116361
The ClinicalTrials.gov registry entry for NCT02116361 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 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 52 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 Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions — of which Normal Saline 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: NCT02116361 reports 20 study locations spanning 5 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 NCT02116361 about?
NCT02116361 is a clinical study titled "OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females". This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
What is the current status of trial NCT02116361?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2014-04-22. Estimated completion is 2016-12-22.
What conditions does trial NCT02116361 study?
This clinical trial studies the following conditions: Depressive Disorder, Major. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02116361?
The interventions under investigation include: Normal Saline (DRUG), onabotulinumtoxinA (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02116361?
This trial is sponsored by Allergan, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02116361 being conducted?
This trial has 20 study locations across Alaska, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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