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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: Completed Phase 3 study of Treatment Outcome, sponsored by Takeda.
NCT01364649 is a Phase 3 study of Treatment Outcome that has completed, run by Takeda. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive ch
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
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01364649 record still lists
NCT01364649 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
Similar trials for Treatment Outcome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01364649's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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