A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Detailed description: 
      1. The objective sleep structures of quetiapine fumarate and haloperidol being used as
           mono-therapy respectively in the treatment of patients with acute schizophrenia are
           measured by the change of composite variables for PSG test (sleep stages, time in bed,
           total sleep time, sleep efficiency, sleep latency) from baseline to Week 4 (LOCF).

        2. The subjective sleep qualities of quetiapine fumarate and haloperidol being used as
           mono-therapy respectively in the treatment of patients with acute schizophrenia are
           measured by the change of Pittsburgh Sleep Quality Inventory (PSQI) and Epworth
           Sleepiness Scale(ESS) from baseline to Week 4 (LOCF).

        3. The clinical efficacy of quetiapine fumarate and haloperidol being used as mono-therapy
           respectively in the treatment of patients with acute schizophrenia are measured by the
           change of Positive and Negative Syndrome Scale (PANSS) and Clinical Globe Impression
           (CGI),and Calgary Depression Scale for Schizophrenia (CDSS) from baseline to Week 4
           (LOCF).

        4. The clinical safety and tolerance quetiapine fumarate and haloperidol being used as
           mono-therapy respectively in the treatment of patients with acute schizophrenia are
           measured by Treatment Emergent Symptom Scale (TESS) in day 14 and day 28.
    

Intervention name(s): quetiapine fumarate; haloperidol
Intervention type(s): Drug; Drug
Intervention description(s): 600-750mg/day; 6-40mg/day
Other intervention name(s): seroquel
Intervention MeSH terms: Haloperidol; Quetiapine Fumarate; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polysomnograph