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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: lurasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868959

D1050256

EUDRACT No. 2008-007483-42

Details and patient eligibility

About

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

Enrollment: 817 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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817 participants in 1 patient group

lurasidone

Experimental group

Treatment:

Drug: lurasidone