OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

Phase 2

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Normal Saline; Biological: onabotulinumtoxinA

• Registration Number: NCT02116361
• Lead Sponsor: Allergan

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

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2014-04-22
• Primary Completion: 2016-08-25
• Study Completion: 2016-12-22
• Status Verified: 2017-11
• Results First Submitted: 2017-11-21
• Results First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Results First Posted: 2017-12-19
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for onabotulinumtoxinA 50 U	Normal Saline	Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U	onabotulinumtoxinA	OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo for onabotulinumtoxinA 30 U	Normal Saline	Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U	onabotulinumtoxinA	OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Primary Outcome Measures

Name	Time	Method
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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	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 Outcome Measures

Name	Time	Method
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)	24 Weeks	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 Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score	Baseline	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.
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score	24 Weeks	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 Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)	Baseline	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.

Trial Locations

Locations (35)

Woodland International Research Group; 🇺🇸 Little Rock, Alaska, United States

CITrials; 🇺🇸 Bellflower, California, United States

Radiant Research/Comprehensive Clinical Development, Inc.; 🇺🇸 Cerritos, California, United States

Collaborative Neuroscience Network Inc.; 🇺🇸 Garden Grove, California, United States

Behavioral Research Specialists, LLC; 🇺🇸 Glendale, California, United States

Excell Research, Inc.; 🇺🇸 Oceanside, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Schuster Medical Research Institute; 🇺🇸 Sherman Oaks, California, United States

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

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