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: March 31, 2014
Last verified: March 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
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
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: NCT00868699

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

Publications:
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: March 31, 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
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 August 20, 2014