BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Overview
- Phase
- Phase 2
- Intervention
- Normal Saline
- Conditions
- Depressive Disorder, Major
- Sponsor
- Allergan
- Enrollment
- 258
- Locations
- 35
- Primary Endpoint
- Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo for onabotulinumtoxinA 50 U
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Intervention: Normal Saline
onabotulinumtoxinA 50 U
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Intervention: onabotulinumtoxinA
Placebo for onabotulinumtoxinA 30 U
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Intervention: Normal Saline
onabotulinumtoxinA 30 U
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Intervention: onabotulinumtoxinA
Outcomes
Primary Outcomes
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Week 6
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Secondary Outcomes
- Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)(24 Weeks)
- Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score(Baseline)
- Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score(24 Weeks)
- Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)(Baseline)