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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01358357Tipo: INTERVENTIONALInicio: 1 de jun de 2011Fin estimado: 1 de abr de 2015

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Open-label Phase
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

Criterios de exclusión

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

Intervenciones

drug

Lurasidone

Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter

drug

Placebo

20-80 mg flexible dose

Ubicaciones

Sanatorio Morra

Córdoba, Córdoba Province, Argentina

Centro de Atencion E Invest. Clinica (CAICI)

Rosario, Santa Fe Province, Argentina

Novain Neurociencias Group

Buenos Aires, Argentina

Centro de Neuropsiquiatria

Buenos Aires, Argentina

IPEM-Instituto de Prevención de las Enfermedades Mentales.

Buenos Aires, Argentina

Instituto DAMCI

Córdoba, Argentina

Clinica Privada de Salud Mental Santa Teresa de Avila

La Plata, Argentina

Centro de Psiquiatria Biologica

Mendoza, Argentina

Patrocinadores

PrincipalSumitomo Pharma America, Inc.

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