SCHIZOPHRENIA MedDRA version: 8.1 Level: LLT Classification code 10039626
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent by one or both parents or by legal guardian prior to any study procedure 2. Provision of written assent by the patient prior to any study procedure 3. Male or female, aged 13 to 17 years at randomization, hospitalized or outpatient 4. If female and of childbearing potential, must be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg, oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation. 5. All female patients will need to have the absence of pregnancy confirmed by a negative b-hCG before randomization 6. DSM-IV criteria for schizophrenia confirmed by the K-SADS-PL 7. The SCQ will be administered to assess for Pervasive Development Disorders. Patients with an SCQ score of > or = 15 and who otherwise meet entrance criteria must have a documented history of delusions or hallucinations. 8. Patients with a secondary diagnosis of depression may continue treatment with an antidepressant if clinically advised by the investigator, providing the antidepressant is permitted by the protocol and the dose has been stable for > or = 30 days preceding randomization 9. PANSS score of > or = 60 and a score of 4 or greater on at least 1 of the following items; delusions (P1), conceptual disorganizations (P2), or hallucinations (P3) at both screening and randomization (Day 1) 10. Willingness to agree not to harm self 11. Have a parent or legal guardian who will accompany the patient at each scheduled study visit, can provide reliable information, and can be responsible for receiving and dispensing study medication 12. Willingness to adhere to the schedule of assessments Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary DSM-IV Axis I diagnoses of Bipolar Disorders including Cyclothymia, Schizophreniform Disorder, Schizoaffective Disorder, Psychotic Disorder Not Otherwise Specified (NOS), and acute ( or = 450 milliseconds at baseline 19. Renal, cardiovascular, hepatic, hematologic, endocrinologic, ophthalmologic, or other disease or clinical finding that is unstable or that in the opinion of the investigator would be negatively affected by study medication or that would affect study medication 20. Unstable Diabetes Mellitus (DM) with a baseline Glycosylated Hemoglobin (HbA1c) Ÿ8.5 21. Patients admitted to a hospital for treatment of diabetes or diabetes related illness in past 12 weeks 22. Not under the care of a physician responsible for the patient’s DM care 23. DM clinically unstable in the opinion of the physician responsible for the patient’s diabetes management at the time of baseline 24. The physician responsible for the patient’s DM care has not approved the patient’s participation in the study 25. The patient has not been on the same dose of oral hypoglycemic drug(s) and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of 2 doses of quetiapine (400 mg/day and 800 mg/day) with that of placebo in the treatment of schizophrenia in adolescent patients as assessed by the change from baseline to Day 42 in the PANSS total score (primary outcome variable). The primary hypotheses are as follows: 1. Quetiapine 400 mg/day is superior to placebo in reducing PANSS total score at Day 42 compared with baseline. 2. Quetiapine 800 mg/day is superior to placebo in reducing PANSS total score at Day 42 compared with baseline.;Secondary Objective: 1. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with the effect of placebo on a broad range of schizophrenia symptoms 2. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with the effect of placebo on level of functioning, as assessed by the change from baseline to Day 42 in the Children’s Global Assessment Scale (CGAS; Shaffer et al 1983) total score 3. to compare the effects of quetiapine 400 mg/day and quetiapine 800 mg/day with the effect of placebo on aggression and hostility, as assessed by the changes from baseline to Days 7, 14, and 42 in the sum of the scores for PANSS items S1, S2, and S3 4. to evaluate the safety and tolerability of quetiapine compared with placebo in the treatment of schizophrenia in adolescent patients;Primary end point(s): Change from baseline to Day 42 in the PANSS total score | — |
Countries
Germany
Outcome results
None listed