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

This study has been completed.
Sponsor:
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
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Bipolar Disorder
Pathologic Processes
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 September 18, 2014