NCT00838032

Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Schizophrenia

Interventions

Type	Name	Description
DRUG	Quetiapine fumarate	Quetiapine fumarate should be initiated on Day 1 and titrated to at least 600 mg/day before Day 7 according to clinical experience and prescribe information. After Day 7, the dose of quetiapine fumarate should be adjusted between 600 mg/day to 750 mg/day at the discretion of the investigator.
DRUG	Haloperidol	Haloperidol should be initiated with the dose range from 5 mg/day to 15 mg/day from Day 1 to Day 5 (using injection) according to the clinical experience and prescribe information. After Day 7, the dose of haloperidol should be adjusted between 8 mg/day to 20 mg/day (change from injection to oral formulation between Day 6 to Day 7) at the discretion of the investigator.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-02-06
• Last updated: 2009-04-01

Locations

1 site across 1 country: China