Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

Condition(s) targeted: Bipolar Disorder

Intervention: Olanzapine Hydrochloride (Drug); Lithium Carbonate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Olanzapine Versus Lithium Carbonate in the Treatment of Bipolar Disorder, Manic or Mixed Episodes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Investigate the efficacy of olanzapine once a day orally for 4 weeks to Lithium Carbonate orally in the treatment of Chinese patients with bipolar I disorder, manic or mixed episodes, with or without psychotic features as measured by the CGI-BP Severity

Secondary outcome:

Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the Y-MRS

Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the BRPs, MADRS.

Assess the safety of olanzapine compared with Lithium Carbonate. Treatment-emergent adverse events, change in vital signs, laboratory analytes and ECG will be measured.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Shanghai, China

Lilly Clinical Trial Registry

Starting date: December 2003
Last updated: June 11, 2007