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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00448578 |
Purpose
This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol. The patients are required to be hospitalised for the treatment and assessment defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis. The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit. At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
| Condition | Intervention | Phase |
|---|---|---|
|
Mania Bipolar Disorder |
Drug: Quetiapine Fumarate Drug: Lithium |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double Dummy & Double Blind, Multicenter, Randomized Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) and Lithium as Monotherapy in the Treatment of Acute Mania in Patients With Bipolar Disorder |
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2005 |
| Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| Research Sites | |
| Beijing, China | |
| Research Site | |
| Guang Zhou, China | |
| Research Site | |
| Kunming, China | |
| Research Site | |
| Nanjing, China | |
| Research Site | |
| Shanghai, China | |
| Research Site | |
| Wu han, China | |
| Study Chair: | Clara Gu | AstraZeneca |
More Information
| ClinicalTrials.gov Identifier: | NCT00448578 History of Changes |
| Other Study ID Numbers: | D1440L00006 |
| Study First Received: | March 16, 2007 |
| Last Updated: | December 7, 2010 |
| Health Authority: | China: State Food and Drug Administration |
|
Acute Mania |
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Lithium Quetiapine 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 |