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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Adiposity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AP Naive

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No