Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders
Information source: Mood Disorders Center of Ottawa
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Quetiapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mood Disorders Center of Ottawa Official(s) and/or principal investigator(s):
Paul Grof, M.D., Principal Investigator, Affiliation: Mood Disorders Center of Ottawa
Anne Duffy, M.D., Principal Investigator, Affiliation: Mood Disorders Center of Ottawa
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 and bipolar II disorders, cyclothymia, and bipolar disorder not otherwise
specified [bipolar NOS]) for a minimum of 48 weeks. Patients will be screened (enrolment
phase) either when already stabilized or during an acute episode of mania/hypomania or
depression.
Clinical Details
Official title: Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders: An Open Prospective Longitudinal Study of the Effectiveness of Quetiapine Monotherapy in Preventing Relapse and Minimizing Neurocognitive Dysfunction Among Adolescents Manifesting Bipolar Spectrum Disorders
Study design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.
Secondary outcome: Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale/Young Mania Rating Scale [MADRS/YMRS] > 15) Time to hospitalization Autobiographical Memory Interview (AMI) mean score over treatment Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion YMRS total score during treatment and at study completion MADRS total score during treatment and at study completion
Eligibility
Minimum age: 12 Years.
Maximum age: 20 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Provide written informed consent before initiation of any study-related procedures.
2. 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).
3. Male or female, between the ages of 12 and 20 years at enrolment.
4. No preventive treatment at least one month prior to enrolment.
5. 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.
6. Able to understand and comply with the requirements of the study.
Exclusion Criteria:
1. Known intolerance or lack of response to quetiapine fumarate as judged by the
investigator.
2. Pregnancy or lactation. Female patients of childbearing potential must have a
negative urine human chorionic gonadotropin (HCG) test at enrolment.
3. History of substance or alcohol dependence within three months of enrolment (except
for caffeine or nicotine dependence), as defined by DSM-IV criteria.
4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV
criteria within 4 weeks prior to enrolment.
5. 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.
6. 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.
7. Current use of fluvoxamine, nefazodone, or grapefruit juice.
8. Thyroid stimulating hormone (TSH) concentration outside of the normal range.
9. Unstable or inadequately treated medical illness (e. g., diabetes, angina pectoris,
hypertension) as judged by the investigator.
10. History of hepatic disease, or elevated hepatic enzymes at entry testing.
11. Medical conditions that would affect absorption, distribution, metabolism, or
excretion of study treatment.
12. Use of an experimental drug within 30 days of enrolment.
13. Previous trials of maintenance therapy.
Locations and Contacts
Mood Disorders Center of Ottawa, Ottawa, Ontario K1G 4G3, Canada
Additional Information
Starting date: June 2004
Ending date: December 2007
Last updated: June 2, 2008
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