Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00868959
First received: March 23, 2009
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression


Condition Intervention Phase
Bipolar Depression
Drug: lurasidone
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Safety and Tolerability of Lurasidone in Subjects, Who Have Completed (ie, Reached 6-week Endpoint) of Study D1050235, Study D1050236 or Study D1050292 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235, Study D1050236 or Study D1050292


Secondary Outcome Measures:
  • Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.

  • Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1="Normal, not ill" to 7="Very severly ill". Higher scores are associated with greater severity.


Enrollment: 813
Study Start Date: April 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lurasidone Drug: lurasidone
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
  • Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235 or Study D1050236

Exclusion Criteria:

  • Imminent risk of suicide, injury to self or to others, or damage to property
  • Subject has evidence of severe movement disorders.
  • Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235 or D1050236)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868959

  Show 151 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00868959     History of Changes
Other Study ID Numbers: D1050256, EUDRACT No. 2008-007483-42
Study First Received: March 23, 2009
Results First Received: February 17, 2014
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health
Canada: Health Canada
China: Ministry of Health
Colombia: National Institutes of Health
Peru: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Slovakia: State Institute for Drug Control

Keywords provided by Sunovion:
Bipolar
Depression
Lurasidone
Latuda

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 22, 2014