Status:
COMPLETED
Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders
Lead Sponsor:
Mood Disorders Center of Ottawa
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
12-20 years
Phase:
PHASE3
Brief Summary
This is a single center, open prospective study to evaluate the effectiveness of quetiapine monotherapy in the maintenance treatment of adolescent patients with a bipolar spectrum disorder (bipolar I ...
Eligibility Criteria
Inclusion
- Provide written informed consent before initiation of any study-related procedures.
- A lifetime diagnosis of bipolar spectrum disorder: bipolar I and bipolar II disorders, cyclothymia, bipolar NOS, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV).
- Male or female, between the ages of 12 and 20 years at enrolment.
- No preventive treatment at least one month prior to enrolment.
- Female patients of childbearing potential and who are sexually active must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.
- Able to understand and comply with the requirements of the study.
Exclusion
- Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
- Pregnancy or lactation. Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- History of substance or alcohol dependence within three months of enrolment (except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment.
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir. Should a new drug be started, investigators will consult the pharmacy as this list is not exhaustive.
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
- Current use of fluvoxamine, nefazodone, or grapefruit juice.
- Thyroid stimulating hormone (TSH) concentration outside of the normal range.
- Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator.
- History of hepatic disease, or elevated hepatic enzymes at entry testing.
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
- Use of an experimental drug within 30 days of enrolment.
- Previous trials of maintenance therapy.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00252226
Start Date
June 1 2004
End Date
December 1 2007
Last Update
June 4 2008
Active Locations (1)
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1
Mood Disorders Center of Ottawa
Ottawa, Ontario, Canada, K1G 4G3