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

NCT02744313 | Completed

• 1 other identifier: 060/2014
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adiposity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in glucose tolerance from baseline to 3 months.

  Baseline and 3 months

• Change in insulin sensitivity from baseline to 3 months.

  Baseline and 3 months

• Body Mass Index (BMI)

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Change in appetite

  Baseline and 3 months

• Change in weight

  Baseline, 4 weeks, 8 weeks, 12 weeks

Other Outcomes (1)

• Quality of life

  Baseline and 3 months

Study Arms (1)

AP Naive

Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance.

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• American Academy of Child Adolescent Psychiatry.: collaborator

Study Sites (1)

Centre For Addiction and Mental Health

Toronto, Ontario, M5T1R8, Canada

Location

Related 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Antipsychotic serum levels, GLP-1, glucagon, cytokines, c-peptide

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Hahn, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)