AdiposityNCT02744313
MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
An observational study of Adiposity, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Adiposity
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AP Naive | Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline and 3 months
Body Mass Index (BMI)
BMI in kg/m^2
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in appetite
Visual analog scale
Measured: Baseline and 3 months
Change in weight
Weight in kilograms
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Responsible party
- Principal investigator, Margaret Hahn, Centre for Addiction and Mental Health
- Investigators
- Margaret Hahn, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744313
- Sponsor's protocol ID
- 060/2014
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
- ClinicalTrials.gov ID
- NCT02744313
- Acronym / sponsor ID
- 060/2014
- Conditions
- Adiposity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AP Naive | – | –Group followed over 12 weeks to measure fat deposition, insulin resistance, and glucose tolerance. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Change in glucose tolerance from baseline to 3 months.
Time frame: Baseline and 3 months
Change in insulin sensitivity from baseline to 3 months.
Time frame: Baseline and 3 months
Body Mass Index (BMI)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in appetite
Time frame: Baseline and 3 months
Change in weight
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- 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 worldLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Hahn, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic and visceral adipose tissue from baseline to 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.