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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Bipolar Depression

Treatments: Drug: lurasidone + (lithium or divalproex); Drug: Placebo + (lithium or divalproex)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868452

D1050235

EUDRACT No. 2008-007482-23

Details and patient eligibility

About

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Enrollment: 348 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
• Subject must be taking lithium or divalproex at least 28 days prior to screening

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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348 participants in 2 patient groups, including a placebo group

Lurasidone

Experimental group

Treatment:

Drug: lurasidone + (lithium or divalproex)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo + (lithium or divalproex)