Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT01358357

Run by

Sumitomo Pharma America, Inc.

People needed

965

Starts

2011-06-01

Expected to finish

2015-04-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Open-label Phase
• 18 years of age or older
• Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder
• ≥ 1 manic, mixed manic, or depressed episode in past 2 years
• YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex
• Double-blind Phase
• Inclusion Criteria:
• Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization

You may not qualify if…

• Open Label Phase
• Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
• Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
• Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
• Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
• Unstable/inadequately treated medical illness
• The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)
• Double Blind Phase
• Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
• Subjects who have not stabilized during the open-label phase (within 20 weeks)
• Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study

Where it is running

• Behavioral Research Specialists, LLC — Glendale, California, United States
• AXIS Clinical Trials — Los Angeles, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• Stanford University School of Medicine Research Program VA Palo Alto Health Care System — Palo Alto, California, United States
• SF-CARE, Inc. — San Francisco, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• "Stanford University School of Medicine — Stanford, California, United States
• Florida Clinical Research LLC — Bradenton, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Galiz Research — Miami Springs, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Clinco — Terre Haute, Indiana, United States
• ActivMed Practices & Research Inc. — Haverhill, Massachusetts, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• Village Clinical Research Inc, — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Charak Center for Health and Wellness — Garfield Heights, Ohio, United States
• Cutting Edge Research Groupd — Oklahoma City, Oklahoma, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• Lincoln Research — Lincoln, Rhode Island, United States
• Carolina Clinical Trials, Inc. — Charleston, South Carolina, United States
• Clinical Neuroscience Solutions Inc. — Memphis, Tennessee, United States
• Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center — Dallas, Texas, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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