OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
NCT ID: NCT02116361
Last Updated: 2017-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
258 participants
INTERVENTIONAL
2014-04-22
2016-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo for onabotulinumtoxinA 50 U
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Normal Saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Placebo for onabotulinumtoxinA 30 U
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Normal Saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Interventions
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onabotulinumtoxinA
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Normal Saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of antidepressant medication for depression within 2 weeks of study
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
18 Years
65 Years
FEMALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Shobhal Patel
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Clinical Neuroscience Solutions, INC
Memphis, Tennessee, United States
KRK Medical Research
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Virginia Commonwealth University Clinical Research Services Unit
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Zain Research LLC
Richland, Washington, United States
Countries
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References
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Brin MF, Durgam S, Lum A, James L, Liu J, Thase ME, Szegedi A. OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females. Int Clin Psychopharmacol. 2020 Jan;35(1):19-28. doi: 10.1097/YIC.0000000000000290.
Other Identifiers
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191622-135
Identifier Type: -
Identifier Source: org_study_id