A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics
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|ClinicalTrials.gov Identifier: NCT00480168|
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : August 28, 2017
|Condition or disease|
Introduction: Antipsychotics have been used for many years to treat serious mental illnesses like schizophrenia and bipolar illness (manic depression). These older drugs carry a higher risk of side effects like shaking, stiffness, restlessness or uncontrolled movements. They may occur when the drugs are first taken, or later, after years of use. Newer drugs called atypical antipsychotics (ATA's) are much less likely to cause these problems. Their lack of these side effects and greater safety have led doctors to use them for other diseases in both adults and younger patients. They have proved to be helpful in aggression, impulsiveness, anxiety and mood swings. Unfortunately, a number of other side effects, such as weight gain, increased rates of diabetes and increases in cholesterol have also been identified. While a lot of current research into these side effects has been done in adults, there have been few studies with younger patients. The research so far has been brief and involved small numbers. This is especially important in this young and potentially vulnerable group of patients.
Study Methods: This research will study children and teens aged 6 to 18 who are being treated with the newer drugs for the first time. If agreeable to the patients and their parents or guardians, their doctors will prescribe one of the newer drugs and will measure the effects, if any, on weight, blood sugar, cholesterol as well as the improvement in their condition. Weight, height, and blood work will be done before the drug is started, and 6 and 12 months after they have been on it, comparing the results with their original values. The doctor, the patient and the parent or guardian will rate the patients' condition at these times, as well, to evaluate their improvement.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||A Prospective Study to Assess Metabolic Changes in Children and Adolescents Aged 6-18 Treated With Atypical Antipsychotics|
|Actual Study Start Date :||July 5, 2005|
|Actual Primary Completion Date :||August 31, 2012|
|Actual Study Completion Date :||August 31, 2012|
- Increase in BMI [ Time Frame: 12 months ]
- Change in glucose and lipids [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480168
|London Health Science Centre|
|London, Ontario, Canada|
|Windsor Regional Hospital|
|Windsor, Ontario, Canada, N8W 1L9|
|Principal Investigator:||Tamison M Doey, MD FRCPC||University of Western Ontario, Canada|