Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00868699
First received: March 23, 2009
Last updated: May 28, 2013
Last verified: May 2013
  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
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group 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:
  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.

    The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.



Secondary Outcome Measures:
  • Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.

    The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.


  • Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]

    Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.

    The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

    The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.



Enrollment: 505
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lurasidone low arm Drug: lurasidone
lurasidone 20 mg/day for Days 1-7
Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator
Experimental: lurasidone high arm Drug: lurasidone
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day

  Eligibility

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

Inclusion Criteria:

  • Subject is diagnosed with bipolar I disorder, most resent episode depressed
  • Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

  • History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
  • Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
  • Imminent risk of suicide or injury to self, others, or property
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868699

  Show 55 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00868699     History of Changes
Other Study ID Numbers: D1050236, EUDRACT No. 2008-007457-13
Study First Received: March 23, 2009
Results First Received: February 14, 2013
Last Updated: May 28, 2013
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
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health

Keywords provided by Sunovion:
Bipolar I, Depression

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 15, 2014