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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

NCT02116361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2017-12-19

Study results available
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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.

Conditions

  • Depressive Disorder, Major

Interventions

BIOLOGICAL

onabotulinumtoxinA

OnabotulinumtoxinA injected into protocol-specified areas on Day 1.

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Shobhal Patel · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-22
Primary Completion
2016-08-25
Completion
2016-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116361 on ClinicalTrials.gov