Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Study Overview
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Brief Summary
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Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among 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 in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Lurasidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent and is 18 to 75 years of age inclusive. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. Has a lifetime history of at least one bipolar manic or mixed manic episode. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after Good physical health on the basis of medical history, physical examination, and laboratory screening. Exclusion Criteria: Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Any chronic organic disease of the CNS (other than Bipolar I Disorder). Hospitalization for a manic or mixed episode within the past two months. Used investigational compound within past 6 months. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 20-120 mg flexible dose<br> | Drug: Lurasidone<br>* Tablets 20-120 mg, PM dosing,daily for 6 weeks<br>* Other names: Latuda;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Equivalent to Lurasidone dosing<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 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) | 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 to week 6 | 
| Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score | SDS 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. | 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, Lurasidone, Latuda