Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

Lilly

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: risperidone; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034580

5528

F1D-US-HGJT

Details and patient eligibility

About

This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female subject, 18-70 years of age
• Female subjects of childbearing potential must be using a medically accepted means of contraception
• Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
• Subjects must be considered reliable

Exclusion:

• Female subjects who are either pregnant or nursing
• Uncorrected hypothyroidism or hyperthyroidism
• Narrow-angle glaucoma
• Subjects who present a serious and immediate risk of endangering him or herself

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind