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Completed

NCT Number: NCT02116361

OnabotulinumtoxinA 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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Woodland International Research Group, Little Rock, Alaska, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

onabotulinumtoxinA

Biological

OnabotulinumtoxinA injected into protocol-specified areas on Day 1.

Other names: BOTOX®, botulinum toxin Type A

normal saline

Drug

Placebo (normal saline) injected into protocol-specified areas on Day 1.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2014
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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