Conditions: Depressive Disorder, Major
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 258
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. arm 2: OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. arm 3: Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. arm 4: OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA injected into protocol-specified areas on Day 1. intervention 2: Placebo (normal saline) injected into protocol-specified areas on Day 1.

Protocol document: