Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448578
Status:
COMPLETED
Last Update Posted:
2010-12-09
First Post:
2007-03-16
Brief Title:
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief Summary:
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 HeShe could be discharged from the hospital after Week 2 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None