OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

Allergan

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder, Major

Treatments: Drug: Normal Saline; Biological: onabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02116361

191622-135

Details and patient eligibility

About

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.

Enrollment: 258 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

258 participants in 4 patient groups, including a placebo group

Placebo for onabotulinumtoxinA 50 U

Placebo Comparator group

Description:

Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.

Treatment:

Drug: Normal Saline

onabotulinumtoxinA 50 U

Experimental group

Description:

OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.

Treatment:

Biological: onabotulinumtoxinA

Placebo for onabotulinumtoxinA 30 U

Placebo Comparator group

Description:

Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Treatment:

Drug: Normal Saline

onabotulinumtoxinA 30 U

Experimental group

Description:

OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Treatment:

Biological: onabotulinumtoxinA