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| Name | Class |
|---|---|
| American Academy of Child Adolescent Psychiatry. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP Naive | Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic and visceral adipose tissue from baseline to 3 months | Adipose tissue is measured by an MRI. Fat content will be compared between baseline and study end (3 months). | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose tolerance from baseline to 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. | Baseline and 3 months |
| Change in insulin sensitivity from baseline to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 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. | Baseline and 3 months |
Inclusion Criteria:
Exclusion Criteria:
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Participants recruited will be selected from clinical settings. Participants will be flagged by their care provider and offered the opportunity to participate should they meet criteria. As well, participants who are interested in the study and may meet criteria can refer themselves to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Hahn, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre For Addiction and Mental Health | Toronto | Ontario | M5T1R8 | Canada |
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| Label | URL |
|---|---|
| The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Antipsychotic serum levels, GLP-1, glucagon, cytokines, c-peptide
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. |
| Baseline and 3 months |
| Body Mass Index (BMI) | BMI in kg/m^2 | Baseline, 4 weeks, 8 weeks, 12 weeks |
| Change in appetite | Visual analog scale | Baseline and 3 months |
| Change in weight | Weight in kilograms | Baseline, 4 weeks, 8 weeks, 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |