Clinical trial NCT00485680: Olanzapine Versus Comparator in the Treatment of Bipolar Disorder
Official title: Olanzapine Versus Lithium Carbonate in the Treatment of Bipolar Disorder, Manic or Mixed Episodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: 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.
measure: Assess the safety of olanzapine compared with Lithium Carbonate. Treatment-emergent adverse events, change in vital signs, laboratory analytes and ECG will be measured.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: