OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.

Key facts

Study ID

NCT02116361

Run by

Allergan

People needed

258

Starts

2014-04-22

Expected to finish

2016-12-22

Last updated by the study team

2017-12-19

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe major depressive disorder

You may not qualify if…

• Prior treatment with botulinum toxin of any serotype for any reason
• Use of antidepressant medication for depression within 2 weeks of study
• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Where it is running

• Woodland International Research Group — Little Rock, Alaska, United States
• CITrials — Bellflower, California, United States
• Radiant Research/Comprehensive Clinical Development, Inc. — Cerritos, California, United States
• Collaborative Neuroscience Network Inc. — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• NRC Research Institute — Orange, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Compass Research LLC-North Clinic — Leesburg, Florida, United States
• Research Centers of America, LLC — Oakland Park, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Institute for Advanced Medical Research — Alpharetta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Uptown Research Institute, LLC — Chicago, Illinois, United States
• Psychiatric Medicine Associates, LLC — Skokie, Illinois, United States
• St. Louis Clinical Trials, LLC — St Louis, Missouri, United States
• Integrative Clinical Trials — Brooklyn, New York, United States
• SPRI Clinical Trials — Brooklyn, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States

Full record on ClinicalTrials.gov

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