RACE : Rapid Dose Escalation of Quetiapine versus Conventional Escalation in the Treatment of Patients with Acute Schizophrenia – a Multicentre, Double-blind, Parallel group, Randomized Study - RACE
- Conditions
- Patients hospitalised with a DSM-IV diagnosis of schizophrenia showing acute agitation and psychosis
- Registration Number
- EUCTR2004-005122-45-DE
- Lead Sponsor
- AstraZeneca GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
For inclusion in the study subjects must fulfil all of the following criteria:
1. Provision of written informed consent prior to enrolment.
2. Men and women age >18 to <65 years
3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for any of the following:
Schizophrenia DSM-IV
catatonic 295.20
disorganised 295.10
paranoid 295.30
undifferentiated 295.90
4. CGI-S score >4
5. PANSS score of >90 at enrolment visit as well as a score of at least 14 on the PANSS-EC, with a score of at least 4 on at least one of 5 items at both enrolment and randomization visits.
6. Female patients of childbearing potential must have a negative serum pregnancy test enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
7. Be able to understand and comply with the requirements of the study, as judged by the investigator.
8. Patient must be hospitalised during the study.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Any of the following is regarded as a criterion for exclusion from the study:
1. Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I disorder not in full remission, concomitant organic mental disorder or mental retardation.
2. Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence.
3. Risk of transmitting HIV or hepatitis B, via blood or other body fluids (as judged by the investigator).
4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
5. Female patients who are pregnant, lactating or at risk of pregnancy.
6. Patients with a history of non-compliance as judged by the investigator.
7. Evidence of clinically relevant disease [...] or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
8. Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the investigator.
9. ECG considered to show clinically significant abnormality at enrolment.
10. A TSH concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism.
11. Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomization day 1.
12. Use of antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic, or other psychoactive drugs within 48 hours before randomization and throughout the randomized period (except medications specified in the protocol)
13. Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 2 weeks prior randomization [...]
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method