A 26-week, International, Multicenter, Open-label Phase IIIbStudy of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™)Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children andAdolescents with Bipolar I Disorder and Adolescents with Schizophrenia - ANCHOR 150
- Conditions
- SCHIZOPHRENIA or BIPOLAR I DISORDER
- Registration Number
- EUCTR2004-000751-42-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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) <70 or diagnosis of mental retardation
4. Psychosis judged to be the direct physiological consequence of a medical condition
or treatment. These conditions include degenerative neurological conditions (eg,
Parkinson’s disease, Huntington’s disease), cerebrovascular disease (eg, stroke),
metabolic conditions (eg, vitamin B12 deficiency), autoimmune conditions (eg,
systemic lupus erythematosus), viral or other infections (eg, hepatitis,
mononucleosis, human immunodeficiency), and cancers.
5. Psychosis judged to be the direct physiological effect (eg, intoxication, withdrawal)
of an abused medication or substance
6. History of any serious suicide attempt that required medical intervention; or current
suicidal risk that cannot be safely managed as determined by the clinical judgment
of the investigator
7. Serious homicidal risk or homicidal behavior within the past 3 months that resulted
in adjudication
8. Known intolerance for or lack of response to quetiapine, as judged by the
investigator
9. Contraindications as detailed in country-specific prescribing information for
quetiapine
10. For female patients, pregnancy or lactation
11. Substance abuse or dependence including alcohol (except for caffeine or nicotine
dependence), as defined in DSM-IV, within 1 month prior to screening
12. Use of depot antipsychotics, eg, haloperidol decanoate, fluphenazine decanoate or risperidone microspheres, within 1 dosing interval of the start of open-label
treatment
13. Electronconvulsive therapy (ECT) within 30 days before enrollment
14. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ketconazole,
itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir,
nelfinavir, ritonavir, and sequinavir) in the 14 days preceding enrollment
15. Use of potent CYP 3A4 inducers (eg, phenytoin, carbamazepine, barbiturates,
rifampin, glucocorticoids, Saint John’s Wort) in the 14 days preceding enrollment
16. Thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range at OL baseline
17. Laboratory test results outside the reference range at OL baseline and considered by the investigator to be clinically significant
18. Baseline QTc interval (Fridericia formula; Puddu et al 1988) > 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
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