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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02116361
First received: April 15, 2014
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Depressive Disorder, Major Biological: onabotulinumtoxinA Drug: Normal Saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures:
  • Change From Baseline in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score [ Time Frame: Baseline, 24 Weeks ]
  • Change From Baseline in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-Dˇ17) [ Time Frame: Baseline, 24 Weeks ]

Enrollment: 258
Study Start Date: April 2014
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: onabotulinumtoxinA Dose 1
OnabotulinumtoxinA Dose 1 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
Experimental: onabotulinumtoxinA Dose 2
OnabotulinumtoxinA Dose 2 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 (normal saline)
Placebo (normal saline) injected into protocol-specified areas on Day 1.
Drug: Normal Saline
Placebo (normal saline) injected into protocol-specified areas on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116361

  Show 35 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Shobhal Patel Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02116361     History of Changes
Other Study ID Numbers: 191622-135
Study First Received: April 15, 2014
Last Updated: February 2, 2017

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Botulinum Toxins
Botulinum Toxins, Type A
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
abobotulinumtoxinA
onabotulinumtoxinA
incobotulinumtoxinA
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

ClinicalTrials.gov processed this record on June 27, 2017