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

Phase 3

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Placebo; Drug: lurasidone

• Registration Number: NCT00868699
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Study Start: 2009-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-02-14
• Results First Submitted QC: 2013-05-28
• Results First Posted: 2013-07-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
lurasidone low arm	lurasidone	-
lurasidone high arm	lurasidone	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)	Baseline to Week 6	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

Name	Time	Method
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	Baseline to Week 6	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	Baseline to Week 6	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.

Trial Locations

Locations (55)

Synergy Escondido,710 East Grand Ave.; 🇺🇸 Escondido, California, United States

Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3; 🇺🇸 Garden Grove, California, United States

Excell Research, Inc,3998 Vista Way,Suite 100; 🇺🇸 Oceanside, California, United States

University of California at Irvine Medical Center; 🇺🇸 Orange, California, United States

California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road; 🇺🇸 Pico Rivera, California, United States

California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor; 🇺🇸 San Diego, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Florida Clinical Research Center, LLC,3914 State Road 64 East; 🇺🇸 Bradenton, Florida, United States

Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230; 🇺🇸 Maitland, Florida, United States

Depression and Anxiety Disorders Research Institute; 🇺🇸 Tampa, Florida, United States

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