Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: Placebo; Drug: lurasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868699

EUDRACT No. 2008-007457-13

D1050236

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: 505 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is diagnosed with bipolar I disorder, most resent episode depressed
• Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion criteria

• History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
• Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
• Imminent risk of suicide or injury to self, others, or property

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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505 participants in 3 patient groups, including a placebo group

lurasidone low arm

Experimental group

Treatment:

Drug: lurasidone

Drug: lurasidone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

lurasidone high arm

Experimental group

Treatment:

Drug: lurasidone

Drug: lurasidone