Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders
This study has been completed.
Sponsor:
Mood Disorders Center of Ottawa
Collaborator:
AstraZeneca
Information provided by:
Mood Disorders Center of Ottawa
ClinicalTrials.gov Identifier:
NCT00252226
First received: November 9, 2005
Last updated: June 2, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Quetiapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mood Disorders Center of Ottawa:
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
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252226
Locations
| Canada, Ontario | |
| Mood Disorders Center of Ottawa | |
| Ottawa, Ontario, Canada, K1G 4G3 | |
Sponsors and Collaborators
Mood Disorders Center of Ottawa
AstraZeneca
Investigators
| Principal Investigator: | Paul Grof, M.D. | Mood Disorders Center of Ottawa |
| Principal Investigator: | Anne Duffy, M.D. | Mood Disorders Center of Ottawa |
More Information
No publications provided
| Responsible Party: | Paul Grof, MDCO |
| ClinicalTrials.gov Identifier: | NCT00252226 History of Changes |
| Other Study ID Numbers: | D1441L00024 |
| Study First Received: | November 9, 2005 |
| Last Updated: | June 2, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Mood Disorders Center of Ottawa:
|
Quetiapine bipolar spectrum disorders |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013