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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Mood Disorders Center of Ottawa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Quetiapine, bipolar spectrum disorders

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Mood Disorders Center of Ottawa

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
YMRS total score during treatment and at study completion
MADRS total score during treatment and at study completion

Full Information

First Posted
November 9, 2005
Last Updated
June 2, 2008
Sponsor
Mood Disorders Center of Ottawa
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00252226
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mood Disorders Center of Ottawa
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Quetiapine, bipolar spectrum disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Grof, M.D.
Organizational Affiliation
Mood Disorders Center of Ottawa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Duffy, M.D.
Organizational Affiliation
Mood Disorders Center of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Center of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada

12. IPD Sharing Statement

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

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