Overview

This trial is active, not recruiting.

Condition depressive disorder, major
Treatments onabotulinumtoxina, normal saline
Phase phase 2
Sponsor Allergan
Start date April 2014
End date August 2016
Trial size 258 participants
Trial identifier NCT02116361, 191622-135

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
OnabotulinumtoxinA Dose 1 injected into protocol-specified areas on Day 1.
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
(Experimental)
OnabotulinumtoxinA Dose 2 injected into protocol-specified areas on Day 1.
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
(Placebo Comparator)
Placebo (normal saline) injected into protocol-specified areas on Day 1.
normal saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.

Primary Outcomes

Measure
Change From Baseline in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
time frame: Baseline, Week 6

Secondary Outcomes

Measure
Change From Baseline in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
time frame: Baseline, 24 Weeks
Change From Baseline in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-Dˇ17)
time frame: Baseline, 24 Weeks

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Allergan.