This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
258
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Placebo (normal saline) injected into protocol-specified areas on Day 1.
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.
Time frame: 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.
Time frame: Week 6
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.
Time frame: 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.
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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
...and 25 more locations
Time frame: 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.
Time frame: 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.
Time frame: 24 Weeks