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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: lurasidone
* Drug: lurasidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lurasidone low arm<br> | Drug: lurasidone<br>* lurasidone 20 mg/day for Days 1-7<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo Comparator<br>|
| Experimental: lurasidone high arm<br> | Drug: lurasidone<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (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. | Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | 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. | Baseline to Week 6 | 
| Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | 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. | Baseline to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar I, Depression