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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116361
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Biological: onabotulinumtoxinA Drug: Normal Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
Actual Study Start Date : April 22, 2014
Actual Primary Completion Date : August 25, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline ]
    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.

  2. Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Week 6 ]
    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 :
  1. Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score [ Time Frame: Baseline ]
    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.

  2. Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score [ Time Frame: 24 Weeks ]
    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.

  3. Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) [ Time Frame: Baseline ]
    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.

  4. Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) [ Time Frame: 24 Weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116361


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Shobhal Patel Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02116361    
Other Study ID Numbers: 191622-135
First Posted: April 16, 2014    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents