Olanzapine Versus Comparator in the Treatment of Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485680
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Olanzapine Hydrochloride
Drug: Lithium Carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Olanzapine Versus Lithium Carbonate in the Treatment of Bipolar Disorder, Manic or Mixed Episodes

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Enrollment: 140
Study Start Date: December 2003
Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485680

Locations
China
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00485680     History of Changes
Other Study ID Numbers: 7598, F1D-GH-LOBV
Study First Received: June 11, 2007
Last Updated: June 11, 2007
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Olanzapine
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on August 28, 2014