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COMPLETED Phase 3

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

NCT01364649 · View on ClinicalTrials.gov ↗

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

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01364649

The ClinicalTrials.gov registry entry for NCT01364649 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01364649 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01364649?

The interventions under investigation include: Placebo (DRUG), Escitalopram (DRUG), Vortioxetine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01364649?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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