Bipolar DisorderPhase 4NCT00181883
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
A Phase 4 study testing quetiapine in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital.
Trial summary
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects, 4-6 years of age.
- Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document.
- Subjects must have an initial score on the Young Mania Rating Scale (Y-MRS) total score of at least 20.
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- Subject must be able to participate in mandatory blood draws.
- Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of the exclusionary criteria.
- For concomitant stimulant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the stimulant therapy will not change throughout the duration of the study.
Who cannot join
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
- Leukopenia or history of leukopenia without a clear and resolved etiology.
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- Judged clinically to be at serious suicidal risk.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
- A non-responder or a history of intolerance to an adequate trial of Quetiapine(2 months or more at an adequate dose) as determined by the clinician.
- Current diagnosis of schizophrenia.
- Non English speaking subjects will not be allowed into the study for the following reasons: a) the assessment instruments are not available and have not been adequately standardized in other languages; b) our clinical trials facility is located in Cambridge and not in the MGH main campus without the availability of translators; c) psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
About this study
Official title: Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Read the detailed description
Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors.
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- quetiapine
- Keywords
- children, bipolar disorder, quetiapine, preschoolers
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
Also called Seroquel
2.5 - 5.0mg/kg PO BID quetiapine
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | 2.5 - 5.0mg/kg PO BID quetiapine
Other Names:
Seroquel Receives: Drug: quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score
The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Wozniak, MD, Massachusetts General Hospital
- Investigators
- Janet Wozniak, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181883
- Sponsor's protocol ID
- 2004-P-001509
- Status last verified
- Mar 2012
- First submitted
- 13 Sep 2005
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Joshi G, Petty C, Wozniak J, Faraone SV, Doyle R, Georgiopoulos A, Hammerness P, Walls S, Glaeser B, Brethel K, Yorks D, Biederman J. A prospective open-label trial of quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder. J Affect Disord. 2012 Feb;136(3):1143-53. doi: 10.1016/j.jad.2011.09.042. Epub 2011 Oct 28.
PubMed 22035648
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00181883
- Acronym / sponsor ID
- 2004-P-001509
- Conditions
- Bipolar Disorder, Mania
- Keywords
- children, bipolar disorder, quetiapine, preschoolers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 6 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Detailed description
Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors.
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: quetiapine2.5 - 5.0mg/kg PO BID quetiapine Other Names: Seroquel |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male or female subjects, 4-6 years of age.
- Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document.
Key exclusion criteria (11 listed)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapineAlso: Seroquel2.5 - 5.0mg/kg PO BID quetiapine | Drug | Quetiapine |
Primary outcome
Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score
Time frame: Baseline to 8 weeks
The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22035648Joshi G, Petty C, Wozniak J, Faraone SV, Doyle R, Georgiopoulos A, Hammerness P, Walls S, Glaeser B, Brethel K, Yorks D, Biederman J. A prospective open-label trial of quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder. J Affect Disord. 2012 Feb;136(3):1143-53. doi: 10.1016/j.jad.2011.09.042. Epub 2011 Oct 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Wozniak, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing quetiapine in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital.
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 9 inclusion and 11 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score (time frame: Baseline to 8 weeks). 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 NCT00181883, which also lists 1 linked publication.
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 6 Apr 2012.