Clinical trial NCT02116361: OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Official title: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-04-16
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe major depressive disorder

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline
measure: Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Week 6
Secondary outcomes:
measure: Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
timeFrame: Baseline
measure: Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
timeFrame: 24 Weeks
measure: Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
timeFrame: Baseline
measure: Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Alaska
city: Bellflower
country: United States
facility: CITrials
state: California
city: Cerritos
country: United States
facility: Radiant Research/Comprehensive Clinical Development, Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Leesburg
country: United States
facility: Compass Research LLC-North Clinic
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates, LLC
state: Illinois
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials, LLC
state: Missouri
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Clinical Research Center
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, INC
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Clinical Research Services Unit
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Richland
country: United States
facility: Zain Research LLC
state: Washington
Study officials:
affiliation: Allergan
name: Shobhal Patel
role: STUDY_DIRECTOR
References:
citation: 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.