Centre For Addiction and Mental Health
Toronto, Ontario, M5T1R8, Canada
NCT Number: NCT02744313
This study will focus on a population of antipsychotic (AP) naïve adolescents and young adults and will measure fat accumulation in relation to exposure to atypical antipsychotic medications.
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Notify Me12 year–35 year
All sexes
Observational
Toronto, Ontario, M5T1R8, Canada
Atypical Antipsychotics (AAPs) are known to cause metabolic dysfunction, and adolescents are especially vulnerable to this effect. The anthropometric measures routinely used to monitor these metabolic side effects may, in fact, underestimate risk in the pediatric population as they are not a good index of hepatic and visceral adipose tissue.
This study will measure fat accumulation over a 12 week period in adolescents and young adults taking an AAP for the first time. MRI imaging will measure hepatic, and visceral adipose tissue at baseline and study end. An Oral Glucose Tolerance Test will measure glucose resistance and insulin sensitivity. In an exploratory fashion, investigators will also image the brain to assess for volumetric changes which may occur in association with AAP treatment and changes in metabolic indices.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 3 months
Adipose tissue is measured by an MRI. Fat content will be compared between baseline and study end (3 months).
Time frame: Baseline and 3 months
An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months). Glucose is measured fasting (mmol/L) at the start of the OGTT and then 2 hours post glucose drink.
Time frame: Baseline and 3 months
An Oral Glucose Tolerance Test (OGTT) will measure these outcomes at baseline and study end (3 months). Insulin is measured fasting (pmol/L) at the start of the OGTT and then 2 hours post glucose drink.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
BMI in kg/m^2
Time frame: Baseline and 3 months
Visual analog scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Weight in kilograms
Time frame: Baseline and 3 months
Assessed with the Pediatric Quality of Life (PedsQL) self-report questionnaire. Items are rated from 1 to 5, with a score of 5 indicating higher levels of quality of life.
Centre for Addiction and Mental Health
Other
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