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 status
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan University
• Treatments: Haloperidol; Haloperidol decanoate; Quetiapine Fumarate

Criteria

Inclusion Criteria:

1. Provision of written informed consent by both patient and legal representative

2. A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3)

3. Male or female, aged 18 to 65 years

4. MOAS total score ³ 10 at both screening and randomization

5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment

6. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Pregnancy or lactation

2. Any CCMD-3 not defined in the inclusion criteria

3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others

4. Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator

5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir

6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids

7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation

8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 criteria

9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 criteria within 4 weeks prior to enrolment

10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment

11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator

12. Involvement in the planning and conduct of the study

13. Previous enrolment or randomisation of treatment in the present study.

14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

15. A patient with Diabetes Mellitus (DM)

16. An absolute neutrophil count (ANC) of £ 1.5 x 109 per liter

17. 2 times higher than the normal upper limit of ALT or AST.

18. Use of clozapine within 28 days prior to randomisation