Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: haloperidol; Drug: placebo; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129220

F1D-JE-BMAC (Other Identifier)

9636

Details and patient eligibility

About

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

Enrollment: 224 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
• Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.

Exclusion criteria

• Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
• The duration of the current episode is more than 90 days at Visit 1.
• Have a history or a diagnosis of diabetes mellitus.
• Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 3 patient groups, including a placebo group

Olanzapine

Experimental group

Description:

olanzapine: 5 to 20 mg per day for 6 weeks

Treatment:

Drug: olanzapine

Haloperidol

Active Comparator group

Description:

haloperidol: 2.5 to 10 mg per day for 6 weeks

Treatment:

Drug: haloperidol

Placebo

Placebo Comparator group

Description:

placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks

Treatment:

Drug: placebo