Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Manic or Mixed Episode Associated With Bipolar I Disorder

Treatments: Drug: carbamazepine; Drug: valproate; Drug: lithium; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266630

F1D-JE-BMEX (Other Identifier)

9637

Details and patient eligibility

About

The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.

Enrollment: 139 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC
• Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed," as determined by the Mini-International Neuropsychiatric Interview (MINI)

Exclusion criteria

• Have a diagnosis of diabetes mellitus
• Significant protocol deviation in Study BMAC
• The actual date of the final visit of Study BMAC is 4 days or more later than the scheduled date of first visit in Study BMEX

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Olanzapine Monotherapy

Experimental group

Description:

Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.

Treatment:

Drug: olanzapine

Olanzapine + Mood Stabilizer

Experimental group

Description:

Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.

Treatment:

Drug: carbamazepine

Drug: olanzapine

Drug: lithium

Drug: valproate