Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

Lilly

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Lithium Carbonate

Drug: Olanzapine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485680

7598

F1D-GH-LOBV

Details and patient eligibility

About

The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female in- or out-patients at least 18 years of age
Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment
Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol
Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2
Patients must be considered reliable

Exclusion criteria

Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
Documented history of intolerance to olanzapine or Lithium Carbonate
Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2