Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
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. 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.