A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on
sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires
during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a
few studies with PSG evaluation had some limitation, such as: small sample size, respective
or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both
subjective and objective effect of quetiapine fumarate in improving sleep quality in
schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study
is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency
by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave
sleep (SWS). The patients will be randomised into two groups as a parallel design. This study
is designed as rater blinded to reduce the bias in evaluation. It is suggested that the
sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks
to ensure the change of sleep quality in this study, which could be helpful for the
evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.