MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use

Centre for Addiction and Mental Health17 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Adiposity

Eligibility

Sex: ALLMin age: 12 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * AP naïve or AP-free for 3 months or greater * prescribed an AP for treatment * age 12-35 * using contraceptive (females of child bearing age) Exclusion Criteria: * currently taking AP or been taking AP for greater than 1 week within the past 3 months * pregnant or planning to become pregnant * eating disorder (active or previous) * clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease * major medical or surgical event in the preceding 3 months * acute suicidal risk

Locations (1)

Centre For Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 3 months

Secondary Outcomes

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.

Time frame: Baseline and 3 months

Change in insulin sensitivity from baseline to 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 and 3 months

Body Mass Index (BMI)

BMI in kg/m\^2

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Change in appetite

Visual analog scale

Time frame: Baseline and 3 months

Change in weight

Weight in kilograms

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Data from ClinicalTrials.gov

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