OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

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

Official Title
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BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Biological: onabotulinumtoxinA
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo for onabotulinumtoxinA 50 U<br>Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. | Drug: Normal Saline<br>* Placebo (normal saline) injected into protocol-specified areas on Day 1.<br>|
| Experimental: onabotulinumtoxinA 50 U<br>OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. | Biological: onabotulinumtoxinA<br>* OnabotulinumtoxinA injected into protocol-specified areas on Day 1.<br>* Other names: botulinum toxin Type A;|
| Placebo Comparator: Placebo for onabotulinumtoxinA 30 U<br>Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. | Drug: Normal Saline<br>* Placebo (normal saline) injected into protocol-specified areas on Day 1.<br>|
| Experimental: onabotulinumtoxinA 30 U<br>OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. | Biological: onabotulinumtoxinA<br>* OnabotulinumtoxinA injected into protocol-specified areas on Day 1.<br>* Other names: botulinum toxin Type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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. | Baseline | 
| Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Baseline | 
| Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | 24 Weeks | 
| Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Baseline | 
| Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | 24 Weeks |