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NCT01564862 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder
A Phase 2 study of Depressive Disorder, Major, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 602
- Enrollment target
- 20
- Study locations
NCT01564862: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Takeda.
NCT01564862 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Takeda. The registered enrollment target is 602 participants, above the 231-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (161% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564862, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 602 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.
Primary Outcome
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Duloxetine
- DRUG vortioxetine (Lu AA21004)
Study Locations (20)
California
- - Bellflower
- - Carson
- - Cerritos
- - Glendale
- - Imperial
- - Los Angeles
- - Norwalk
- - Oakland
- - Paramount
- - San Bernardino
- - Santa Ana
- - Wildomar
Florida
- - Lauderhill
- - Miami
- - Orlando
Colorado
- - Colorado Springs
- - Denver
Arizona
- - Tucson
Arkansas
- - Little Rock
Connecticut
- - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT01564862 record still lists
NCT01564862 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, above the 231-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (161% higher).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01564862 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01564862 about?
NCT01564862 is a clinical study titled "Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder". The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.
What is the current status of trial NCT01564862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 602 participants. The study started on 2012-04. Estimated completion is 2014-02.
What conditions does trial NCT01564862 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT01564862?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG), vortioxetine (Lu AA21004) (DRUG).
Who is sponsoring clinical trial NCT01564862?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01564862 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
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 NCT01564862's enrollment target sits among peer trials
602 6th of 52 higher than 47 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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.
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