A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics
2 other identifiers
observational
50
1 country
2
Brief Summary
The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis being treated with drugs called atypical antipsychotics to determine the effects of the drugs on growth, weight gain, and laboratory tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2005
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2005
CompletedFirst Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2012
CompletedAugust 28, 2017
August 1, 2017
7.2 years
May 25, 2007
August 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in BMI
12 months
Secondary Outcomes (1)
Change in glucose and lipids
12 months
Eligibility Criteria
Community sample of youth 6-18 where treatment with atypical antipsychotic medication is being initiated
You may qualify if:
- Atypical Antipsychotic naive patients who have agreed to take Atypical Antipsychotic medication upon the recommendation of their physician based on the child and their symptoms as per their usual patient care
- Outpatients and inpatients
- A wide range of patients including those with ADHD, Tourette's disorder, anxiety, disruptive behavior and mood instability as well as psychosis
- Children and adolescents aged 6 through 18 years
- Both sexes
- Females who have reached menarche and are sexually active who agree to use adequate birth control
- Patients who are willing to give informed assent/consent
- Guardians willing to give informed consent, if needed
- No initiation of or changes of doses of other psychotropic medication prescribed for the indication of which the atypical antipsychotic is being prescribed in the preceding month.
You may not qualify if:
- Patients with eating disorders (this condition might affect the expected weight and metabolic changes anticipated with the medications)
- Concurrent medical conditions including diabetes or hyperlipidemia if, in the judgment of the treating physician, the use of atypical anti-psychotics would be contra-indicated. (patient safety)
- Substance abuse (may effect the reliability of the patients or confound weight or metabolic effects of the medications)
- Pregnant or lactating patients (patient safety)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
London Health Science Centre
London, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, N8W 1L9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamison M Doey, MD FRCPC
The University of Western Ontario
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 30, 2007
Study Start
July 5, 2005
Primary Completion
August 31, 2012
Study Completion
August 31, 2012
Last Updated
August 28, 2017
Record last verified: 2017-08