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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
onabotulinumtoxinA
Normal Saline
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Woodland International Research Group
  • CITrials
  • Radiant Research/Comprehensive Clinical Development, Inc.
  • Collaborative Neuroscience Network Inc.
  • Behavioral Research Specialists, LLC
  • Excell Research, Inc.
  • NRC Research Institute
  • Artemis Institute for Clinical Research
  • Schuster Medical Research Institute
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Compass Research LLC-North Clinic
  • Research Centers of America, LLC
  • Clinical Neuroscience Solutions, Inc
  • Compass Research, LLC
  • Stedman Clinical Trials
  • Institute for Advanced Medical Research
  • Atlanta Center for Medical Research
  • iResearch Atlanta, LLC
  • Uptown Research Institute, LLC
  • Psychiatric Medicine Associates, LLC
  • St. Louis Clinical Trials, LLC
  • Integrative Clinical Trials
  • SPRI Clinical Trials
  • Finger Lakes Clinical Research
  • Midwest Clinical Research Center
  • IPS Research Company
  • Oklahoma Clinical Research Center
  • Summit Research Network (Oregon) Inc.
  • Clinical Neuroscience Solutions, INC
  • KRK Medical Research
  • InSite Clinical Research
  • Virginia Commonwealth University Clinical Research Services Unit
  • Northwest Clinical Research Center
  • Zain Research LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo for onabotulinumtoxinA 50 U

onabotulinumtoxinA 50 U

Placebo for onabotulinumtoxinA 30 U

onabotulinumtoxinA 30 U

Arm Description

Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.

OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.

Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 15, 2014
Last Updated
November 21, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02116361
Brief Title
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Official Title
BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 22, 2014 (Actual)
Primary Completion Date
August 25, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo for onabotulinumtoxinA 50 U
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Arm Title
onabotulinumtoxinA 50 U
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Arm Title
Placebo for onabotulinumtoxinA 30 U
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Arm Title
onabotulinumtoxinA 30 U
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Placebo (normal saline) injected into protocol-specified areas on Day 1.
Primary Outcome Measure Information:
Title
Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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
Title
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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
Secondary Outcome Measure Information:
Title
Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Description
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
Title
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Description
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
24 Weeks
Title
Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Description
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
Title
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shobhal Patel
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Alaska
ZIP/Postal Code
72211
Country
United States
Facility Name
CITrials
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Radiant Research/Comprehensive Clinical Development, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Compass Research LLC-North Clinic
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Research Centers of America, LLC
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Uptown Research Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Psychiatric Medicine Associates, LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
St. Louis Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Integrative Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
SPRI Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Neuroscience Solutions, INC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Virginia Commonwealth University Clinical Research Services Unit
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Zain Research LLC
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31609787
Citation
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.
Results Reference
derived

Learn more about this trial

OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

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