AzTrials
AzTrials

Bipolar DisorderPhase 3NCT00252226

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

A Phase 3 study testing Quetiapine in people with Bipolar Disorder, run by Mood Disorders Center of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 12 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder
What is being tested?
Quetiapine
How many people
100 participants
Where
1 siteCanada
Study dates
Jun 2004to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mood Disorders Center of Ottawa

    Ottawa, Ontario, K1G 4G3

Other trials in Canada

About this study

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

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.

Being tested
Quetiapine
Keywords
Quetiapine, bipolar spectrum disorders
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuetiapineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Time to an episode recurrence (Montgomery-Asberg Depression Rating Scale

  2. /Young Mania Rating Scale [MADRS/YMRS] > 15)

  3. Time to hospitalization

  4. Autobiographical Memory Interview (AMI) mean score over treatment

  5. Clinical Global Impression-Bipolar Disorder (CGI-BP) score during treatment and at study completion

  6. YMRS total score during treatment and at study completion

  7. MADRS total score during treatment and at study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00252226
Sponsor's protocol ID
D1441L00024
Status last verified
Jun 2008
First submitted
9 Nov 2005
Last updated
4 Jun 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine in people with Bipolar Disorder, run by Mood Disorders Center of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of treated study patients maintained on monotherapy for the duration of the trial compared to the proportion requiring systematic adjunctive medication.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00252226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in