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NCT01421134 · ClinicalTrials.gov registry record · Phase 3
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
A Phase 3 study of Major Depressive Disorder With Mixed Features, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
- 20
- Study locations
NCT01421134: Completed Phase 3 study of Major Depressive Disorder With Mixed Features, sponsored by Sumitomo Pharma America.
NCT01421134 is a Phase 3 study of Major Depressive Disorder With Mixed Features that has completed, run by Sumitomo Pharma America. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421134, a Phase 3 study of Major Depressive Disorder With Mixed Features, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
- 20
- Study locations
Study Summary
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
Primary Outcome
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lurasidone
Study Locations (20)
California
- Synergy Clinical Research Center - Escondido
- Collaborative Neuroscience Network Inc. - Garden Grove
- Stanford -VA Palo Alto Health Care System - Palo Alto
- Clinical Innovations Inc. - Riverside
- Artemis Institute for Clinical Research - San Diego
New York
- Social Psychiatric Research Inst. (SPRI) Clinical Trials - Brooklyn
- Village Clinical Research Inc. - New York
- Finger Lakes Clinical Research - Rochester
- Behavioral Medical Research of Staten Island - Staten Island
Texas
- FutureSearch Trials of Dallas, LP - Dallas
- Dept. of Psychiatry, UT Southwestern Medical Center - Dallas
- Grayline Clinical Drug Trials - Wichita Falls
Alabama
- Birmingham Psychiatry Pharmaceutical Studies, Inc. - Birmingham
Florida
- Florida Clinical Research Center, LLC - Sarasota
Massachusetts
- Massachusetts General Hospital - Center for Anxiety and Traumatic Stress Disorders - Boston
Missouri
- St. Charles Psychiatric Associates/Midwest Research Group - Saint Charles
North Carolina
- Psychiatry and Behavioral Sciences, Duke - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01421134 record still lists
NCT01421134 is an interventional study that assigns participants to a tested intervention. The registered 211 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 (73% lower).
The record links to 1 condition, with Major Depressive Disorder With Mixed Features appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01421134 names 20 study sites across 11 states, led by California, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT01421134 about?
NCT01421134 is a clinical study titled "Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose". Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
What is the current status of trial NCT01421134?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2011-09. Estimated completion is 2014-10.
What conditions does trial NCT01421134 study?
This clinical trial studies the following conditions: Major Depressive Disorder With Mixed Features.
What interventions are being tested in trial NCT01421134?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01421134?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421134 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421134's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 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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