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Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

NCT01358357•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This study is 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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

Exclusion Criteria

•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)
+1 more criteria

Locations (105)

Harmonex Neuroscience Research

Dothan, Alabama, United States

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

Key Dates

Start Date

June 1, 2011

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

September 7, 2016

Enrollment

965

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

Lurasidone

DRUG

Placebo

DRUG

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

SchizophreniaBipolar I Disorder

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RECRUITINGPHASE3

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

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Bipolar DisorderBipolar Depression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

ERG Components in Schizophrenia and Bipolar Disorder Type I

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)