Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Study Overview
=================
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

Official Title
-----------------
A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

Conditions
-----------------
Bipolar Depression

Intervention / Treatment
-----------------
* Drug: lurasidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study D1050236, NCT#008668699. Exclusion Criteria: Imminent risk of suicide, injury to self or to others, or damage to property Subject has evidence of severe movement disorders. Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452 or D1050236, NCT#008688699).

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lurasidone<br> | Drug: lurasidone<br>* Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment | Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a clinician-rated assessment of the subject's level of depression. Ten items are rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity. | 24 weeks | 
| Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) | This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity. | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar, Depression, Lurasidone, Latuda