Acute Schizophrenia Clinical Trial
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China.
Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for
the patient population. Some evidence showed that quetiapine fumarate could control
aggression and agitation within 1 week, which is appropriate for the acute treatment of
patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of
psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate
timeframe for the evaluation of clinical effect of agitation and aggression symptoms
controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of
750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's
prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine
fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a
small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation
potential for weight gain and prolactin elevation, quetiapine fumarate should be well
tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day)
(Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate
with daily dose 600-750mg/day in improving agitation and aggression for the treatment of
Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of
2 weeks
Agitation and aggression are the common symptoms in the acute schizophrenic patients. Under
these symptoms, schizophrenic patients could be harmful to themselves as well as the
environment and people surrounding. Patients' agitation and aggression are also part of the
reason for their hospitalisation. Therefore, rapid controlling of agitation and aggression
for the patients is critical to ensure their treatment adherence, so that patients could stay
with their treatment for a long time. Some studies have already provided the methods for
rapid control, of which haloperidol is a common medication. However, use of haloperidol will
bring patients prominent adverse reaction, such as extropyromidal symptoms etc., which will
lead to the poor adherence of patients and caregivers and finally increase the treatment risk
rather than benefit, such as relapse, re-hospitalization, and poor social functioning etc.
Quetiapine fumarate, a dibenzothiazepine derivative, is an atypical antipsychotic drug
approved for treatment of schizophrenia, bipolar mania, and bipolar depression by FDA in many
countries worldwide. In China, it has been used for the treatment of patients with
schizophrenia for approximately 10 years. Quetiapine has the advantage of broad symptoms
controlling, individualized dose range, and most important, good efficacy and tolerability in
the acute treatment for schizophrenic patients.
Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China.
Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for
the patient population. Some evidence showed that quetiapine fumarate could control
aggression and agitation within 1 week, which is appropriate for the acute treatment of
patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of
psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate
timeframe for the evaluation of clinical effect of agitation and aggression symptoms
controlling.
In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of
750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's
prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine
fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a
small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation
potential for weight gain and prolactin elevation, quetiapine fumarate should be well
tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day)
(Peuskens 2004).
The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate
with daily dose 600-750mg/day in improving agitation and aggression for the treatment of
Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of
2 weeks This is a 2-week, single-blinded, randomised, parallel-group haloperidol-controlled
pilot study. After given of informed consent and undergoing screening procedures, the
patients will be allocated to study treatment on Day 1. Patients should have a diagnosis of
schizophrenia by CCMD-3 criteria with MOAS total score at least 10. Eligible patients will be
randomised into quetiapine group or haloperidol group with 1-week dose titration (at least
600 mg/day for quetiapine and 8 mg/day for haloperidol after Day 7). After that, the patients
should be treated by the defined dose range for another week.
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