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NCT02116361 · ClinicalTrials.gov registry record · Phase 2
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
A Phase 2 study of Depressive Disorder, Major, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
- 20
- Study locations
NCT02116361: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Allergan.
NCT02116361 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Allergan. The registered enrollment target is 258 participants, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02116361, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
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 |
What the finished NCT02116361 record still lists
NCT02116361 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target.
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.
NCT02116361 names 20 study sites across 5 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT02116361?
The interventions under investigation include: Normal Saline (DRUG), onabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT02116361?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
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 NCT02116361's enrollment target sits among peer trials
258 16th of 52 higher than 36 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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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