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

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2004-005122-45-DE
• Date of registration: 04/10/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca GmbH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 18/05/2005
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005122-45
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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 [...]


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients hospitalised with a DSM-IV diagnosis of schizophrenia showing acute agitation and psychosis

Intervention(s)

Trade Name: Seroquel 25mg Filmtabletten
Product Name: Seroquel 25mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Seroquel 100 mg Filmtabletten
Product Name: Seroquel 100 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Seroquel 200 mg Filmtabletten
Product Name: Seroquel 200 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Seroquel 300 mg Filmtabletten
Product Name: Seroquel 300 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine fumarate
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment

Main Objective: The primary objective for the study is to evaluate the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme (300 mg on day 1, 600 mg on day 2 and 800 mg on day 3) compared to the current approved label titration (50 mg on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, 400 mg on day 5, 600 mg on day 6 and 800 mg on day 7). The safety profile of both titration schemes will be measured with the proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment.

Secondary Objective: 1. To evaluate if the initiation with 300 mg on day 1 is safe and well tolerated in the treatment of severely ill acute schizophrenic patients.
2. To evaluate if increasing the dosing up to 800mg on day 3 is safe and has a similar tolerability to the current label in the treatment of severely ill acute schizophrenic patients.
3. To evaluate if dosing with 800 mg from day 3 to day 7 is safe and has a similar tolerability to the current label in the treatment of severely ill acute schizophrenic patients.
4. To evaluate if there is a comparable safety and tolerability during the 12 days of treatment.
5. To evaluate if there is a comparable safety/tolerability profile between both titration schemes on EPS, measured by SAS and BARS.
6. To evaluate if the faster titration will provide a faster onset of efficacy measured by PANSS-EC, CGI.

Secondary ID(s)

D1441L00032