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

Phase 3

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: lurasidone

• Registration Number: NCT00868959
• Lead Sponsor: Sumitomo Pharma America, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Study Start: 2009-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-02-17
• Results First Submitted QC: 2014-02-17
• Results First Posted: 2014-04-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 817

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lurasidone	lurasidone	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment	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)

Secondary Outcome Measures

Name	Time	Method
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)	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.
Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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.

Trial Locations

Locations (147)

Woodland International Research Inc; 🇺🇸 Little Rock, Arkansas, United States

South Coast Clinical Trials Inc.; 🇺🇸 Anaheim, California, United States

Catalina Research Institute; 🇺🇸 Chino, California, United States

Clinical Innovations Inc.; 🇺🇸 Santa Ana, California, United States

Synergy Escondido; 🇺🇸 Escondido, California, United States

Collaborative Neuroscience Network Inc; 🇺🇸 Garden Grove, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Florida Clinical Research Center LLC; 🇺🇸 Fruitland park, Florida, United States

Excell Research, Inc; 🇺🇸 Oceanside, California, United States

University of California at Irvine Medical Center; 🇺🇸 Orange, California, United States

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