Clinical trial NCT00252226: Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Quetiapine
bipolar spectrum disorders
Lead sponsor: Mood Disorders Center of Ottawa
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.
Secondary outcomes:
measure: Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale
measure: /Young Mania Rating Scale [MADRS/YMRS] > 15)
measure: Time to hospitalization
measure: Autobiographical Memory Interview (AMI) mean score over treatment
measure: Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion
measure: YMRS total score during treatment and at study completion
measure: MADRS total score during treatment and at study completion
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Mood Disorders Center of Ottawa
state: Ontario
Study officials:
affiliation: Mood Disorders Center of Ottawa
name: Paul Grof, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mood Disorders Center of Ottawa
name: Anne Duffy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: