drugset / Trial / NCT02116361
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 30 unknown | Other |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 unknown | Other |