At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 258 enrolled
Drug / intervention
onabotulinumtoxinA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
In Brief
A Phase 2 clinical trial evaluating onabotulinumtoxinA and Normal Saline for Depressive Disorder, Major. Completed, enrolled 258 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartApr 2014
Primary CompletionAug 2016
Study CompletionDec 2016
TodayJul 2026
First PostedApr 16, 2014
Enrollment StartApr 22, 2014
Primary CompletionAug 25, 2016
Study CompletionDec 22, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.2 years ago
Interventions
onabotulinumtoxinAbiological
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Normal Salinedrug
Placebo (normal saline) injected into protocol-specified areas on Day 1.