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NCT01179516 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

A Phase 3 study of Depressive Disorder, Major, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
469
Enrollment target
20
Study locations

NCT01179516 is a Phase 3 study of Depressive Disorder, Major that has completed, run by Takeda. The registered enrollment target is 469 participants, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT01179516, a Phase 3 study of Depressive Disorder, Major, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
469 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Conditions Studied

Depressive Disorder, Major

Interventions

  • DRUG Placebo
  • DRUG Vortioxetine

Study Locations (20)

California

  • - Carson
  • - Cerritos
  • - El Centro
  • - Fresno
  • - Glendale
  • - Los Angeles
  • - Oakland
  • - Oceanside
  • - San Diego
  • - Santa Ana
  • - Sherman Oaks
  • - Stanford
  • - Upland

Florida

  • - Fort Walton Beach
  • - Kissimmee
  • - Miami

Arkansas

  • - Little Rock

Colorado

  • - Denver

Connecticut

  • - Hartford

Delaware

  • - Hockessin

Trial Details

FieldValue
Enrollment Target 469 participants
Start Date 2010-08
Est. Completion 2012-06
Phase Phase 3

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT01179516

The ClinicalTrials.gov registry entry for NCT01179516 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 469 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 233-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (101% higher). The listed sponsor is Takeda, which has 408 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 Placebo is the first listed.

NCT01179516 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01179516 about?

NCT01179516 is a clinical study titled "Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

What is the current status of trial NCT01179516?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2010-08. Estimated completion is 2012-06.

What conditions does trial NCT01179516 study?

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

What interventions are being tested in trial NCT01179516?

The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).

Who is sponsoring clinical trial NCT01179516?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01179516 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.