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NCT01284517 · ClinicalTrials.gov registry record · Phase 3
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
A Phase 3 study of Bipolar Depression, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
- 20
- Study locations
NCT01284517: Completed Phase 3 study of Bipolar Depression, sponsored by Sumitomo Pharma America.
NCT01284517 is a Phase 3 study of Bipolar Depression that has completed, run by Sumitomo Pharma America. The registered enrollment target is 356 participants, above the 204-participant average among 29 other Bipolar Depression trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284517, a Phase 3 study of Bipolar Depression, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
- 20
- Study locations
Study Summary
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
Primary Outcome
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lurasidone
Study Locations (20)
California
- Clinical Innovations, Inc. - Costa Mesa
- Clinical Innovations Inc. - Riverside
- Artemis Institute for Clinical Research - San Diego
- Sharp Mesa Vista Hospital - San Diego
- Clinical Innovations inc. - Santa Ana
- Collaborative Neuroscience Network - Torrance
Florida
- Accurate Clinical Trials - Kissimmee
- Clinical Neuroscience Solutions Inc. - Orlando
Georgia
- Northwest Behavioral Research Center - Roswell
- Institute for Behavioral Medicine LLC - Smyrna
New York
- Village Clinical Research Inc. - New York
- Medical & Behavioral Health Research - New York
Texas
- FutureSearch Clinical Trials, LP - Dallas
- Pillar Clinical Research - Dallas
Colorado
- Colorado Clinical Trials Inc. - Highlands Ranch
Mississippi
- Precise Research Centers - Flowood
North Carolina
- Zarzar Psychiatric Associates, PLLC - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT01284517 record still lists
NCT01284517 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, above the 204-participant average among 29 other Bipolar Depression trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01284517 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01284517 about?
NCT01284517 is a clinical study titled "Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression". Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
What is the current status of trial NCT01284517?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2010-11. Estimated completion is 2012-08.
What conditions does trial NCT01284517 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT01284517?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01284517?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01284517 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Depression
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 NCT01284517's enrollment target sits among peer trials
356 9th of 29 higher than 21 of 29 other Bipolar Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Depression 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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