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NCT02116361 · ClinicalTrials.gov registry record · Phase 2

OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

A Phase 2 study of Depressive Disorder, Major, sponsored by Allergan.

Completed
Registry status
Phase 2
Development phase
258
Enrollment target
20
Study locations

NCT02116361 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Allergan. The registered enrollment target is 258 participants, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT02116361, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 2
Development phase
258 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Normal Saline
  • BIOLOGICAL onabotulinumtoxinA

Study Locations (20)

California

  • CITrials - Bellflower
  • Radiant Research/Comprehensive Clinical Development, Inc. - Cerritos
  • Collaborative Neuroscience Network Inc. - Garden Grove
  • Behavioral Research Specialists, LLC - Glendale
  • Excell Research, Inc. - Oceanside
  • NRC Research Institute - Orange
  • Artemis Institute for Clinical Research - San Diego
  • Schuster Medical Research Institute - Sherman Oaks

Florida

  • Sarkis Clinical Trials - Gainesville
  • Clinical Neuroscience Solutions, Inc. - Jacksonville
  • Compass Research LLC-North Clinic - Leesburg
  • Research Centers of America, LLC - Oakland Park
  • Clinical Neuroscience Solutions, Inc - Orlando
  • Compass Research, LLC - Orlando
  • Stedman Clinical Trials - Tampa

Georgia

  • Institute for Advanced Medical Research - Alpharetta
  • Atlanta Center for Medical Research - Atlanta
  • iResearch Atlanta, LLC - Decatur

Alaska

  • Woodland International Research Group - Little Rock

Illinois

  • Uptown Research Institute, LLC - Chicago

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2014-04-22
Est. Completion 2016-12-22
Phase Phase 2

Sponsor

Allergan

314 total trials

What the Registry Record Tells You About NCT02116361

The ClinicalTrials.gov registry entry for NCT02116361 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.

NCT02116361 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT02116361 about?

NCT02116361 is a clinical study titled "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.

What is the current status of trial NCT02116361?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2014-04-22. Estimated completion is 2016-12-22.

What conditions does trial NCT02116361 study?

This clinical trial studies the following conditions: Depressive Disorder, Major.

What interventions are being tested in trial NCT02116361?

The interventions under investigation include: Normal Saline (DRUG), onabotulinumtoxinA (BIOLOGICAL).

Who is sponsoring clinical trial NCT02116361?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02116361 being conducted?

This trial has 20 study locations across Alaska, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depressive Disorder, Major

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.