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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

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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

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE April 16, 2014
Results First Submitted Date  ICMJE November 21, 2017
Results First Posted Date  ICMJE December 19, 2017
Last Update Posted Date December 19, 2017
Actual Study Start Date  ICMJE April 22, 2014
Actual Primary Completion Date August 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
Change From Baseline in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Official Title  ICMJE BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Biological: onabotulinumtoxinA
    OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
    Other Names:
    • BOTOX®
    • botulinum toxin Type A
  • Drug: Normal Saline
    Placebo (normal saline) injected into protocol-specified areas on Day 1.
Study Arms  ICMJE
  • Placebo Comparator: Placebo for onabotulinumtoxinA 50 U
    Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
    Intervention: Drug: Normal Saline
  • Experimental: onabotulinumtoxinA 50 U
    OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
    Intervention: Biological: onabotulinumtoxinA
  • Placebo Comparator: Placebo for onabotulinumtoxinA 30 U
    Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
    Intervention: Drug: Normal Saline
  • Experimental: onabotulinumtoxinA 30 U
    OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
    Intervention: Biological: onabotulinumtoxinA
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2016)
258
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2014)
140
Actual Study Completion Date  ICMJE December 22, 2016
Actual Primary Completion Date August 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02116361
Other Study ID Numbers  ICMJE 191622-135
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shobhal Patel Allergan
PRS Account Allergan
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP