OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
1 other identifier
interventional
258
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedStudy Start
First participant enrolled
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedResults Posted
Study results publicly available
December 19, 2017
CompletedDecember 19, 2017
November 1, 2017
2.3 years
April 15, 2014
November 21, 2017
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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.
Baseline
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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.
Week 6
Secondary Outcomes (4)
Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Baseline
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
24 Weeks
Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Baseline
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
24 Weeks
Study Arms (4)
Placebo for onabotulinumtoxinA 50 U
PLACEBO COMPARATORPlacebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U
EXPERIMENTALOnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo for onabotulinumtoxinA 30 U
PLACEBO COMPARATORPlacebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U
EXPERIMENTALOnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Interventions
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Placebo (normal saline) injected into protocol-specified areas on Day 1.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (35)
Woodland International Research Group
Little Rock, Alaska, 72211, United States
CITrials
Bellflower, California, 90706, United States
Radiant Research/Comprehensive Clinical Development, Inc.
Cerritos, California, 90703, United States
Collaborative Neuroscience Network Inc.
Garden Grove, California, 92845, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Compass Research LLC-North Clinic
Leesburg, Florida, 34748, United States
Research Centers of America, LLC
Oakland Park, Florida, 33334, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076, United States
St. Louis Clinical Trials, LLC
St Louis, Missouri, 63141, United States
Integrative Clinical Trials
Brooklyn, New York, 11229, United States
SPRI Clinical Trials
Brooklyn, New York, 11235, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Clinical Neuroscience Solutions, INC
Memphis, Tennessee, 38119, United States
KRK Medical Research
Dallas, Texas, 75230, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Virginia Commonwealth University Clinical Research Services Unit
Richmond, Virginia, 23298, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Zain Research LLC
Richland, Washington, 99352, United States
Related Publications (1)
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.
PMID: 31609787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arlene Lum, PMP
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Shobhal Patel
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 16, 2014
Study Start
April 22, 2014
Primary Completion
August 25, 2016
Study Completion
December 22, 2016
Last Updated
December 19, 2017
Results First Posted
December 19, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share