SCHIZOPHRENIA or BIPOLAR I DISORDER
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. Prior participation in Study D1441C00149 or Study D1441C00112 for > or = 14 days 4. Male or female; aged 13 to 17 years at randomization of Study D1441C00112 or aged 10 to 17 years at baseline of Study D1441C00149. Patients who become 18 years of age after entering Study D1441C00112 or D1441C00149 will be permitted to enter this OL study. 5. 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. 6. All female patients will need to have the absence of pregnancy confirmed by a negative serum beta hCG before OL baseline 7. DSM-IV criteria for schizophrenia or bipolar I disorder, confirmed by the K-SADS-PL at entry into the preceding double-blind Study D1441C00149 or Study D1441C00112 8. Willingness to agree not to harm self 9. 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 10. 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) 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
Exclusion criteria: 1. DSM-IV Axis I diagnoses of Schizophreniform Disorder, Schizoaffective Disorder, Psychotic Disorder Not Otherwise Specified (NOS), Bipolar II Disorder, Bipolar Disorder Not Otherwise Specified (NOS) 2. An interval greater than 7 days between the last double-blind study visit (OL baseline) and Day 1 3. Premorbid intelligence quotient (IQ) or = 450 milliseconds at OL 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 an OL baseline HgbA1c > or = 8.5 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 OL 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 diet f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the safety and tolerability of quetiapine in children and adolescent patients with Bipolar I disorder and in adolescents with schizophrenia who are treated with doses of 400 mg/day to 800 mg/day for up to 26 weeks. The primary objective will be assessed by: - the incidence and nature of overall AEs - the rate of patient withdrawal due to AEs - the changes from the open-label baseline to Week 26 in clinical laboratory test results, vital signs, weight, BMI, ECG results, and physical examination findings. The OL baseline will be defined as the final assessment in the preceding double-blind study (D1441C00149 or D1441C00112). - the changes from OL baseline to Week 26 in the Simpson-Angus Scale total score, the Barnes Akathisia Rating Scale global score, and the Abnormal Involuntary Movement Scale total score - the proportion of patients treated with anticholinergic medication for emergent EPS;Secondary Objective: Secondary objectives are as follows: 1. to evaluate the growth and development of patients receiving long-term treatment with quetiapine at doses of 400 mg/day to 800 mg/day, as assessed by change from OL baseline to Week 26 in the Tanner Stage, initiation of or changes in menses for female patients, and changes from OL baseline to Week 26 in weight and BMI 2. to evaluate the level of functioning in patients receiving long-term treatment with quetiapine at doses of 400 mg/day to 800 mg/day, as assessed by changes from OL baseline to Week 26 in the Children’s Global Assessment Scale (CGAS; Shaffer et al 1983) score;Primary end point(s): The primary study variables are as follows: - the incidence and nature of overall AEs from OL baseline to Week 26 - the rate of patient withdrawal due to AEs - the changes from OL baseline to Week 26 in clinical laboratory test results (eg, prolactin concentration), vital signs, weight, BMI, ECG results, and physical examination findings - the changes from OL basel | — |
Countries
Germany
Outcome results
None listed