OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

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

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 Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Normal Saline; Biological: onabotulinumtoxinA

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Little Rock, Alaska, United States, 72211
      • Woodland International Research Group
  • California
    • Bellflower, California, United States, 90706
      • CITrials
    • Cerritos, California, United States, 90703
      • Radiant Research/Comprehensive Clinical Development, Inc.
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network Inc.
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Orange, California, United States, 92868
      • NRC Research Institute
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Leesburg, Florida, United States, 34748
      • Compass Research LLC-North Clinic
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America, LLC
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Institute for Advanced Medical Research
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute, LLC
    • Skokie, Illinois, United States, 60076
      • Psychiatric Medicine Associates, LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • St. Louis Clinical Trials, LLC
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon) Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
  • Texas
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Clinical Research Services Unit
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Richland, Washington, United States, 99352
      • Zain Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo for onabotulinumtoxinA 50 U; Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.	Drug: Normal Saline; Placebo (normal saline) injected into protocol-specified areas on Day 1.
Experimental: onabotulinumtoxinA 50 U; OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.	Biological: onabotulinumtoxinA; OnabotulinumtoxinA injected into protocol-specified areas on Day 1.; Other Names: BOTOX®; botulinum toxin Type A
Placebo Comparator: Placebo for onabotulinumtoxinA 30 U; Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.	Drug: Normal Saline; Placebo (normal saline) injected into protocol-specified areas on Day 1.
Experimental: onabotulinumtoxinA 30 U; OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.	Biological: onabotulinumtoxinA; OnabotulinumtoxinA injected into protocol-specified areas on Day 1.; Other Names: BOTOX®; botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Shobhal Patel, Allergan

Publications and helpful links

General Publications

• Brin MF, Durgam S, Lum A, James L, Liu J, Thase ME, Szegedi A. OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females. Int Clin Psychopharmacol. 2020 Jan;35(1):19-28. doi: 10.1097/YIC.0000000000000290.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2014
• Primary Completion (Actual): August 25, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 191622-135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No