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NCT01575561 · ClinicalTrials.gov registry record · Phase 3
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
A Phase 3 study of Bipolar I Disorder, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 377
- Enrollment target
- 20
- Study locations
NCT01575561: Completed Phase 3 study of Bipolar I Disorder, sponsored by Sumitomo Pharma America.
NCT01575561 is a Phase 3 study of Bipolar I Disorder that has completed, run by Sumitomo Pharma America. The registered enrollment target is 377 participants, above the 315-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575561, a Phase 3 study of Bipolar I Disorder, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 377 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
Primary Outcome
Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
Conditions Studied
Interventions
- DRUG Lurasidone
Study Locations (20)
California
- Behavioral Research Specialists, LLC - Glendale
- AXIS Clinical Trials - Los Angeles
- Excell Research, Inc - Oceanside
- Stanford University School of Medicine Research Program VA Palo Alto Health Care System - Palo Alto
- SF-Care, Inc. - San Francisco
- Neuropsychiatric Research Center of Orange County - Santa Ana
- Stanford University School of Medicine - Stanford
Florida
- Florida Clinical Research LLC - Bradenton
- Clinical Neuroscience Solutions Inc. - Jacksonville
- Galiz Research - Miami Springs
- Clinical Neuroscience Solutions - Orlando
Alabama
- Harmonex Neuroscience Research - Dothan
Georgia
- Atlanta Center for Medical Research - Atlanta
Indiana
- Clinco - Terre Haute
Massachusetts
- Activ Med Practices & Research - Haverhill
Missouri
- Psych Care Consultants Research - St Louis
New York
- Finger Lakes Clinical Research - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01575561 record still lists
NCT01575561 is an interventional study that assigns participants to a tested intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap, above the 315-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 1 intervention - of which Lurasidone is the first listed.
NCT01575561 names 20 study sites across 11 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01575561 about?
NCT01575561 is a clinical study titled "This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296". This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D...
What is the current status of trial NCT01575561?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 377 participants. The study started on 2012-06. Estimated completion is 2015-07.
What conditions does trial NCT01575561 study?
This clinical trial studies the following conditions: Bipolar I Disorder.
What interventions are being tested in trial NCT01575561?
The interventions under investigation include: Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01575561?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01575561 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
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 NCT01575561's enrollment target sits among peer trials
377 7th of 26 higher than 20 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder 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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