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Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00252226•Mood Disorders Center of Ottawa

View on ClinicalTrials.gov

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

Age

12 - 20 years

Sex

ALL

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (1)

Mood Disorders Center of Ottawa

Ottawa, Ontario, Canada

Key Dates

Start Date

June 1, 2004

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

June 4, 2008

Enrollment

100

ESTIMATED participants

Conditions

Bipolar Disorder

Interventions

Quetiapine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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