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

Adiposity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744313
• Other study ID #: 060/2014
• Status: Completed
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity

Locations

Country	Name	City	State
Canada	Centre For Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	American Academy of Child Adolescent Psychiatry.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Body Mass Index (BMI)	BMI in kg/m^2	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Change in appetite	Visual analog scale	Baseline and 3 months
Secondary	Change in weight	Weight in kilograms	Baseline, 4 weeks, 8 weeks, 12 weeks

External 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