Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 23, 2009
March 31, 2014
April 2009
February 2012   (final data collection date for primary outcome measure)
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.

Mean change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint (Week 6) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00868699 on ClinicalTrials.gov Archive Site
  • 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.

  • Mean change from baseline to endpoint (Week 6) in: • Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline to endpoint (Week 6) in: • Sheehan Disability Scale (SDS) total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Bipolar Depression
  • 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
  • Drug: lurasidone
    lurasidone 20 mg/day for Days 1-7
  • Drug: Placebo
    Placebo Comparator
  • Experimental: lurasidone low arm
    Intervention: Drug: lurasidone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: lurasidone high arm
    Intervention: Drug: lurasidone
Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb 1;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
505
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   India,   Romania,   Russian Federation,   South Africa,   Ukraine
 
NCT00868699
D1050236, EUDRACT No. 2008-007457-13
Yes
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP