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OpenTrials
Completed

NCT Number: NCT02744313

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

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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Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre For Addiction and Mental Health

Toronto, Ontario, M5T1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in hepatic and visceral adipose tissue from baseline to 3 months

    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).

Secondary outcomes

  1. Change in glucose tolerance from baseline to 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.

  2. Change in insulin sensitivity from baseline to 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). Insulin is measured fasting (pmol/L) at the start of the OGTT and then 2 hours post glucose drink.

  3. Body Mass Index (BMI)

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

    BMI in kg/m^2

  4. Change in appetite

    Time frame: Baseline and 3 months

    Visual analog scale

  5. Change in weight

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

    Weight in kilograms

Other outcomes

  1. Quality of life

    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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • American Academy of Child Adolescent Psychiatry.

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2016
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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