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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

NCT00838032 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2009-04-01

No results posted yet for this study

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

Conditions

  • Acute Schizophrenia

Interventions

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.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Tao Chun Liu, Director · Huaxi hospital affiliated to Sichuan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838032 on ClinicalTrials.gov