Depressive Disorder, Major Clinical Trial
Official title:
BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Verified date | November 2017 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
Status | Completed |
Enrollment | 258 |
Est. completion date | December 22, 2016 |
Est. primary completion date | August 25, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Advanced Medical Research | Alpharetta | Georgia |
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | CITrials | Bellflower | California |
United States | Integrative Clinical Trials | Brooklyn | New York |
United States | SPRI Clinical Trials | Brooklyn | New York |
United States | Radiant Research/Comprehensive Clinical Development, Inc. | Cerritos | California |
United States | Uptown Research Institute, LLC | Chicago | Illinois |
United States | KRK Medical Research | Dallas | Texas |
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | iResearch Atlanta, LLC | Decatur | Georgia |
United States | InSite Clinical Research | DeSoto | Texas |
United States | Sarkis Clinical Trials | Gainesville | Florida |
United States | Collaborative Neuroscience Network Inc. | Garden Grove | California |
United States | Behavioral Research Specialists, LLC | Glendale | California |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | Compass Research LLC-North Clinic | Leesburg | Florida |
United States | Woodland International Research Group | Little Rock | Alaska |
United States | Clinical Neuroscience Solutions, INC | Memphis | Tennessee |
United States | Research Centers of America, LLC | Oakland Park | Florida |
United States | Excell Research, Inc. | Oceanside | California |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | Oklahoma Clinical Research Center | Oklahoma City | Oklahoma |
United States | NRC Research Institute | Orange | California |
United States | Clinical Neuroscience Solutions, Inc | Orlando | Florida |
United States | Compass Research, LLC | Orlando | Florida |
United States | Summit Research Network (Oregon) Inc. | Portland | Oregon |
United States | Zain Research LLC | Richland | Washington |
United States | Virginia Commonwealth University Clinical Research Services Unit | Richmond | Virginia |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | St. Louis Clinical Trials, LLC | Saint Louis | Missouri |
United States | Artemis Institute for Clinical Research | San Diego | California |
United States | Schuster Medical Research Institute | Sherman Oaks | California |
United States | Psychiatric Medicine Associates, LLC | Skokie | Illinois |
United States | Stedman Clinical Trials | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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