Phase 3 Completed N=817 Treatment

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

Depression

Source: ClinicalTrials.gov NCT00868959 ↗

Enrolled (actual)

817

Serious AEs

2.9%

Results posted

Apr 2014

Primary outcomePrimary: Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment — 529 participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment	529	—
SECONDARY Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-4.4	—
SECONDARY 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)	-0.58	—

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00868959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.