Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex (PERSIST)

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Bipolar I Disorder

Treatments

Drug: Lurasidone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358357

D1050296

2011-000986-10 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

965 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

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

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)
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