Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed

Lilly

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618748

F1D-JE-HGMS (Other Identifier)

11682

Details and patient eligibility

About

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

Full description

This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Enrollment: 101 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be aged 18 to less than 75 years.
2. Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
3. All female patients must test negative for pregnancy.
4. Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
5. Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
6. Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
7. Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
8. Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.

Exclusion criteria

1. Is investigator site personnel directly affiliated with this study or their immediate families.
2. Is a Lilly employee.
3. Has previously completed or withdrawn from this study or any other study investigating olanzapine.
4. Is pregnant or nursing.
5. Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

Pre-Olanzapine

Experimental group

Description:

Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.

Treatment:

Drug: Olanzapine

Pre-Placebo

Experimental group

Description:

Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.

Treatment:

Drug: Olanzapine

New Olanzapine

Experimental group

Description:

Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.

Treatment:

Drug: Olanzapine