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

NCT00252226 | Completed Phase 3

• 1 other identifier: D1441L00024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Quetiapine; bipolar spectrum disorders

Outcome Measures

Primary Outcomes (1)

• Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.

Secondary Outcomes (7)

• 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

Interventions

Quetiapine DRUG

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Provide written informed consent before initiation of any study-related procedures.
• 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).
• Male or female, between the ages of 12 and 20 years at enrolment.
• No preventive treatment at least one month prior to enrolment.
• 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.
• Able to understand and comply with the requirements of the study.

You may not qualify if:

• Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
• Pregnancy or lactation. Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
• History of substance or alcohol dependence within three months of enrolment (except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment.
• 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.
• 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.
• Current use of fluvoxamine, nefazodone, or grapefruit juice.
• Thyroid stimulating hormone (TSH) concentration outside of the normal range.
• Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator.
• History of hepatic disease, or elevated hepatic enzymes at entry testing.
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
• Use of an experimental drug within 30 days of enrolment.
• Previous trials of maintenance therapy.

Sponsors & Collaborators

• Mood Disorders Center of Ottawa: lead
• AstraZeneca: collaborator

Study Sites (1)

Mood Disorders Center of Ottawa

Ottawa, Ontario, K1G 4G3, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul Grof, M.D.

  Mood Disorders Center of Ottawa

  PRINCIPAL INVESTIGATOR

• Anne Duffy, M.D.

  Mood Disorders Center of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

CA (1)