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Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders

NCT ID: NCT00252226

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Quetiapine bipolar spectrum disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quetiapine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Mood Disorders Center of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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MDCO

Principal Investigators

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Paul Grof, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mood Disorders Center of Ottawa

Anne Duffy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mood Disorders Center of Ottawa

Locations

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Mood Disorders Center of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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D1441L00024

Identifier Type: -

Identifier Source: org_study_id