Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder

NCT00181883 | Completed Phase 4 Results DMC

• 1 other identifier: 2004-P-001509
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

children; bipolar disorder; quetiapine; preschoolers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 8 weeks

Study Arms (1)

Quetiapine

EXPERIMENTAL

2.5 - 5.0mg/kg PO BID quetiapine Other Names: Seroquel

Drug: quetiapine

Interventions

quetiapine DRUG

2.5 - 5.0mg/kg PO BID quetiapine

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Subject must be able to participate in mandatory blood draws.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (1)

• 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.

  PMID: 22035648 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Janet Wozniak, MD
• Organization: Massachusetts General Hospital

jwozniak@partners.org

617-503-1038

Study Officials

• Janet Wozniak, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 6, 2012
• Results First Posted: April 6, 2012

Record last verified: 2012-03