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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252226
• Other study ID #: D1441L00024
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: June 2, 2008
• Start date: June 2004
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: Mood Disorders Center of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 20 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
Canada	Mood Disorders Center of Ottawa	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mood Disorders Center of Ottawa	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.
Secondary	Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale
Secondary	/Young Mania Rating Scale [MADRS/YMRS] > 15)
Secondary	Time to hospitalization
Secondary	Autobiographical Memory Interview (AMI) mean score over treatment
Secondary	Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion
Secondary	YMRS total score during treatment and at study completion
Secondary	MADRS total score during treatment and at study completion