OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116361
• Other study ID #: 191622-135
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2014
• Last updated: November 21, 2017
• Start date: April 22, 2014
• Est. completion date: December 22, 2016

Study information

• Verified date: November 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Biological:
• onabotulinumtoxinA
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.

Drug:
• Normal Saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

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