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.

Study Overview

• Status: Completed
• Conditions: Adiposity

Detailed Description

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 (Actual): 17

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
AP Naive; Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: American Academy of Child Adolescent Psychiatry.
• Investigators: Principal Investigator: Margaret Hahn, MD, PhD, Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 060/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO