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NCT01358357 · ClinicalTrials.gov registry record · Phase 3
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
A Phase 3 study of Bipolar I Disorder, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 965
- Enrollment target
- 20
- Study locations
NCT01358357 is a Phase 3 study of Bipolar I Disorder that has completed, run by Sumitomo Pharma America. The registered enrollment target is 965 participants, above the 293-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (229% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT01358357, a Phase 3 study of Bipolar I Disorder, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 965 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.
Conditions Studied
Interventions
- DRUG Placebo
- 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
New York
- Village Clinical Research Inc, - New York
- Finger Lakes Clinical Research - Rochester
Alabama
- Harmonex Neuroscience Research - Dothan
Georgia
- Atlanta Center for Medical Research - Atlanta
Indiana
- Clinco - Terre Haute
Massachusetts
- ActivMed Practices & Research Inc. - Haverhill
Missouri
- Psych Care Consultants Research - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 965 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01358357
The ClinicalTrials.gov registry entry for NCT01358357 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 965 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 293-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (229% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01358357 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT01358357 about?
NCT01358357 is a clinical study titled "Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex". This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psy...
What is the current status of trial NCT01358357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 965 participants. The study started on 2011-06. Estimated completion is 2015-04.
What conditions does trial NCT01358357 study?
This clinical trial studies the following conditions: Bipolar I Disorder.
What interventions are being tested in trial NCT01358357?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01358357?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01358357 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.
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Related
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