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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00190892 |
This trial will assess any efficacious benefit and any safety issues associated with the concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I disorder, manic or mixed episodes
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: olanzapine Drug: carbamazepine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Olanzapine Plus Carbamazepine Versus Carbamazepine Alone in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder |
Estimated Enrollment: | 120 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Queensland | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Everton Park, Queensland, Australia | |
Australia, Victoria | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Frankston, Victoria, Australia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Epping, Victoria, Australia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Malvern, Victoria, Australia | |
Greece | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Corfu, Greece, 491 00 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Tripoli, Greece, 221 00 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Kavala, Greece, 654 03 | |
Hungary | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Budapest, Hungary | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Gyula, Hungary | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Debrecen, Hungary | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Szekesfehervar, Hungary | |
Russian Federation | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Moscow, Russian Federation | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
St. Petersburg, Russian Federation |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 7031, F1D-MC-HGKR |
Study First Received: | September 12, 2005 |
Last Updated: | January 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00190892 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants Antipsychotic Agents Antimanic Agents Serotonin Uptake Inhibitors |
Serotonin Affective Disorders, Psychotic Carbamazepine Mental Disorders Analgesics, Non-Narcotic Mood Disorders Psychotic Disorders Analgesics Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Affective Disorders, Psychotic Pathologic Processes Sensory System Agents Mental Disorders Therapeutic Uses Analgesics Disease Tranquilizing Agents |
Bipolar Disorder Gastrointestinal Agents Central Nervous System Depressants Antimanic Agents Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Carbamazepine Autonomic Agents Analgesics, Non-Narcotic Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |