Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
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|ClinicalTrials.gov Identifier: NCT00868959|
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : April 1, 2014
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: lurasidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||817 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
- Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment [ Time Frame: 24 weeks ]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)
- Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 24 weeks ]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.
- 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) [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868959
|Study Director:||Medical Director, MD||Sunovion|