A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

CompletadoFase 3ClinicalTrials.gov

ID: NCT01575561Tipo: INTERVENTIONALInicio: 1 de jun de 2012Fin estimado: 1 de jul de 2015

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Resumen

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

Descripción detallada

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder. Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1). Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subject has agreed to participate by providing written informed consent.
Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Criterios de exclusión

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).

Intervenciones

drug

Lurasidone

Lurasidone 20-80 mg taken orally once daily

Ubicaciones

Clinica Privada de Salud Mental Santa Teresa de Avila

Buenos Aires, Argentina

Novain Neurociencias Group

Buenos Aires, Argentina

Instituto Nacional de Psicopatología (INAPSI)

Buenos Aires, Argentina

Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)

Buenos Aires, Argentina

Instituto DAMIC SRL

Córdoba, Argentina

Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

Rosario, Argentina

Patrocinadores

PrincipalSumitomo Pharma America, Inc.

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