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NCT01364649 · ClinicalTrials.gov registry record · Phase 3

Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction

A Phase 3 study of Treatment Outcome, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
447
Enrollment target
20
Study locations

NCT01364649 is a Phase 3 study of Treatment Outcome that has completed, run by Takeda. The registered enrollment target is 447 participants. The trial reports 20 study locations across 6 states.

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The verdict

NCT01364649, a Phase 3 study of Treatment Outcome, has completed, sponsored by Takeda.

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

Study Summary

The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Escitalopram
  • DRUG Vortioxetine

Study Locations (20)

California

  • - Anaheim
  • - Chino
  • - Costa Mesa
  • - Encino
  • - Escondido
  • - Irvine
  • - Newport Beach
  • - Oceanside
  • - San Diego

Florida

  • - Coral Springs
  • - Fort Myers
  • - Gainesville
  • - Jacksonville
  • - Lauderhill
  • - North Miami
  • - Orlando

Alabama

  • - Birmingham

Arizona

  • - Tucson

Connecticut

  • - Norwich

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 447 participants
Start Date 2011-06
Est. Completion 2013-12
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT01364649

The ClinicalTrials.gov registry entry for NCT01364649 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Treatment Outcome appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01364649 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT01364649 about?

NCT01364649 is a clinical study titled "Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction". The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

What is the current status of trial NCT01364649?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2011-06. Estimated completion is 2013-12.

What conditions does trial NCT01364649 study?

This clinical trial studies the following conditions: Treatment Outcome.

What interventions are being tested in trial NCT01364649?

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

Who is sponsoring clinical trial NCT01364649?

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

Where is trial NCT01364649 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. 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.