Status:
UNKNOWN
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
Lead Sponsor:
Sichuan University
Conditions:
Acute Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 popu...
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 ...
Eligibility Criteria
Inclusion
- Provision of written informed consent by both patient and legal representative
- A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3)
- Male or female, aged 18 to 65 years
- MOAS total score ³ 10 at both screening and randomization
- 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
- Able to understand and comply with the requirements of the study
Exclusion
- Pregnancy or lactation
- Any CCMD-3 not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator
- 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
- 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
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM)
- An absolute neutrophil count (ANC) of £ 1.5 x 109 per liter
- 2 times higher than the normal upper limit of ALT or AST.
- Use of clozapine within 28 days prior to randomisation
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00838032
Start Date
August 1 2008
End Date
May 1 2010
Last Update
April 1 2009
Active Locations (1)
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1
Mental Health Center of Huaxi Hospital affiliated to Sichuan University
Chengdu, Sichuan, China, 610041