Phase 2
Completed N=258
OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT02116361 ↗
Enrolled (actual)
258
Serious AEs
3.5%
Results posted
Dec 2017
Primary outcomePrimary: Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — 31.4; 32.0; 32.4; 32.0 Scores on a Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
31.4; 32.0; 32.4; 32.0 | — |
| PRIMARY Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-7.9; -11.6; -12.9; -11.5 | — |
| SECONDARY Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score |
4.2; 4.4; 4.4; 4.5 | — |
| SECONDARY Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score |
-1.4; -1.9; -2.6; -2.9 | — |
| SECONDARY Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) |
23.7; 24.5; 23.3; 23.0 | — |
| SECONDARY Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) |
-11.5; -13.4; -16.1; -17.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02116361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.