drugset / Trial / NCT02116361

OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

NCT02116361 ↗

Phase 2 Completed 258 enrolled Allergan
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-04-22
Primary completion
2016-08-25
Completion
2016-12-22

Outcome

Missed primary endpoint

paper OnabotA 30 U approached significance compared to placebo on MADRS (mixed-effect model repeated measures least-squares mean difference: -3.7; P = 0.053) PMID 31609787 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 30 unknown Other
Subject Botulinum toxin type A Protein / enzyme biologic 50 unknown Other