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

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 when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: lurasidone + (lithium or divalproex)
* Drug: Placebo + (lithium or divalproex)


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 Subject must be taking lithium or divalproex at least 28 days prior to screening 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<br> | Drug: lurasidone + (lithium or divalproex)<br>* lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo + (lithium or divalproex)<br>* 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7<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) | MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Baseline, 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) | CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Baseline Week 6 | 
| Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening. | Baselin Week 6 | 

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