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

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): Schuster Medical Research Institute
🇺🇸
Sherman Oaks, California, United States
InSite Clinical Research
🇺🇸
DeSoto, Texas, United States
Zain Research LLC
🇺🇸
Richland, Washington, United States
Woodland International Research Group
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Little Rock, Alaska, United States
Northwest Clinical Research Center
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Bellevue, Washington, United States
NRC Research Institute
🇺🇸
Orange, California, United States
Radiant Research/Comprehensive Clinical Development, Inc.
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Cerritos, California, United States
Artemis Institute for Clinical Research
🇺🇸
San Diego, California, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
Uptown Research Institute, LLC
🇺🇸
Chicago, Illinois, United States
Psychiatric Medicine Associates, LLC
🇺🇸
Skokie, Illinois, United States
IPS Research Company
🇺🇸
Oklahoma City, Oklahoma, United States
Oklahoma Clinical Research Center
🇺🇸
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
🇺🇸
Portland, Oregon, United States
KRK Medical Research
🇺🇸
Dallas, Texas, United States
CITrials
🇺🇸
Bellflower, California, United States
Behavioral Research Specialists, LLC
🇺🇸
Glendale, California, United States
Excell Research, Inc.
🇺🇸
Oceanside, California, United States
Compass Research LLC-North Clinic
🇺🇸
Leesburg, Florida, United States
iResearch Atlanta, LLC
🇺🇸
Decatur, Georgia, United States
Integrative Clinical Trials
🇺🇸
Brooklyn, New York, United States
SPRI Clinical Trials
🇺🇸
Brooklyn, New York, United States
Finger Lakes Clinical Research
🇺🇸
Rochester, New York, United States
Collaborative Neuroscience Network Inc.
🇺🇸
Garden Grove, California, United States
Research Centers of America, LLC
🇺🇸
Oakland Park, Florida, United States
St. Louis Clinical Trials, LLC
🇺🇸
Saint Louis, Missouri, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Jacksonville, Florida, United States
Institute for Advanced Medical Research
🇺🇸
Alpharetta, Georgia, United States
Clinical Neuroscience Solutions, INC
🇺🇸
Memphis, Tennessee, United States
Midwest Clinical Research Center
🇺🇸
Dayton, Ohio, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸
Orlando, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Stedman Clinical Trials
🇺🇸
Tampa, Florida, United States
Virginia Commonwealth University Clinical Research Services Unit
🇺🇸
Richmond, Virginia, United States