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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sunovion
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01358357
First received: May 19, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Bipolar I Disorder
Drug: Lurasidone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Time to recurrence of mood event during the double blind treatment phase [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to all-cause discontinuation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of a manic, mixed manic, hypomanic, or depressed episode [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who experience a recurrence of a manic, mixed manic, hypomanic, or depressed episode [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from double-blind phase baseline to endpoint in global severity (CGI-B, severity of Illness score) YMRS, MADRS, QIDS - SR16 total score and PANSS-P [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Subject self-report of functional impairment associated with symptoms of bipolar disorder, assessed by the Sheehan Disability Scale (SDS) total score and SDS subscales [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionaire-Short Form (Q-LES-Q-SF) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Sleep Quality assessed by the Pittsburgh Insomnia Rating Scale (PIRS-2) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Health outcome measures: Health Services Utilization Questionaire (HSUQ) and the SF-12 Health Survey [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Medication Satisfaction Questionaire (MSQ) [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with adverse events (AEs), discontinuation due to AEs, and serious AEs (SAEs) [ Time Frame: 28 Weeks ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS, physical examination results [ Time Frame: 28 Weeks ] [ Designated as safety issue: Yes ]
  • Weight, laboratory measures, vital signs, and electrocardiograms (ECGs) [ Time Frame: 28 Weeks ] [ Designated as safety issue: Yes ]
  • Movement disorders, as assessed by Abnormal Involuntary Movement Scale(AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS) [ Time Frame: 28 Weeks ] [ Designated as safety issue: Yes ]
  • Physical Examination [ Time Frame: 28 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1060
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 20-80 mg flexible dose Drug: Lurasidone
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
Placebo Comparator: Placebo Drug: Placebo
20-80 mg flexible dose

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358357

Contacts
Contact: Study Manager 1-888-394-7377

  Show 127 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01358357     History of Changes
Other Study ID Numbers: D1050296, 2011-000986-10
Study First Received: May 19, 2011
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Pública de Chile
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Japan: Pharmaceutical and Medical Devices Agency

Keywords provided by Sunovion:
Lurasidone
Latuda
Bipolar I

ClinicalTrials.gov processed this record on July 20, 2014