Adverse EffectsNCT00480168
A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics
An observational study of Adverse Effects, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis being treated with drugs called atypical antipsychotics to determine the effects of the drugs on growth, weight gain, and laboratory tests. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Adverse Effects
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Jul 2005to 31 Aug 2012
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Community sample of youth 6-18 where treatment with atypical antipsychotic medication is being initiated
Who may be able to join
- Atypical Antipsychotic naive patients who have agreed to take Atypical Antipsychotic medication upon the recommendation of their physician based on the child and their symptoms as per their usual patient care
- Outpatients and inpatients
- A wide range of patients including those with ADHD, Tourette's disorder, anxiety, disruptive behavior and mood instability as well as psychosis
- Children and adolescents aged 6 through 18 years
- Both sexes
- Females who have reached menarche and are sexually active who agree to use adequate birth control
Show all 9Show fewer
- Patients who are willing to give informed assent/consent
- Guardians willing to give informed consent, if needed
- No initiation of or changes of doses of other psychotropic medication prescribed for the indication of which the atypical antipsychotic is being prescribed in the preceding month.
Who cannot join
- Patients with eating disorders (this condition might affect the expected weight and metabolic changes anticipated with the medications)
- Concurrent medical conditions including diabetes or hyperlipidemia if, in the judgment of the treating physician, the use of atypical anti-psychotics would be contra-indicated. (patient safety)
- Substance abuse (may effect the reliability of the patients or confound weight or metabolic effects of the medications)
- Pregnant or lactating patients (patient safety)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Science Centre
London, Ontario
Windsor Regional Hospital
Windsor, Ontario, N8W 1L9
About this study
Official title: A Prospective Study to Assess Metabolic Changes in Children and Adolescents Aged 6-18 Treated With Atypical Antipsychotics
The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis being treated with drugs called atypical antipsychotics to determine the effects of the drugs on growth, weight gain, and laboratory tests.
Read the detailed description
Introduction: Antipsychotics have been used for many years to treat serious mental illnesses like schizophrenia and bipolar illness (manic depression). These older drugs carry a higher risk of side effects like shaking, stiffness, restlessness or uncontrolled movements. They may occur when the drugs are first taken, or later, after years of use. Newer drugs called atypical antipsychotics (ATA's) are much less likely to cause these problems. Their lack of these side effects and greater safety have led doctors to use them for other diseases in both adults and younger patients. They have proved to be helpful in aggression, impulsiveness, anxiety and mood swings. Unfortunately, a number of other side effects, such as weight gain, increased rates of diabetes and increases in cholesterol have also been identified. While a lot of current research into these side effects has been done in adults, there have been few studies with younger patients. The research so far has been brief and involved small numbers. This is especially important in this young and potentially vulnerable group of patients.
Study Methods: This research will study children and teens aged 6 to 18 who are being treated with the newer drugs for the first time. If agreeable to the patients and their parents or guardians, their doctors will prescribe one of the newer drugs and will measure the effects, if any, on weight, blood sugar, cholesterol as well as the improvement in their condition. Weight, height, and blood work will be done before the drug is started, and 6 and 12 months after they have been on it, comparing the results with their original values. The doctor, the patient and the parent or guardian will rate the patients' condition at these times, as well, to evaluate their improvement.
- Conditions
- Adverse Effects
- Keywords
- child, adolescent, weight gain, endocrine disruptors
- Medical subject headings
- Weight Gain
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in BMI
Measured: 12 months
Secondary outcomes (1)
Change in glucose and lipids
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study start5 Jul 2005
- Primary completion31 Aug 2012
- Study completion31 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamison M Doey, MD FRCPC, Principal investigator, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480168
- Sponsor's protocol ID
- R-05-116
- Other IDs
- 11172
- Status last verified
- Aug 2017
- First submitted
- 25 May 2007
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess Metabolic Changes in Children and Adolescents Aged 6-18 Treated With Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT00480168
- Acronym / sponsor ID
- R-05-116
- Conditions
- Adverse Effects
- Keywords
- child, adolescent, weight gain, endocrine disruptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 5 Jul 2005 (actual)
- Primary completion
- 31 Aug 2012 (actual)
- Study completion
- 31 Aug 2012 (actual)
- First posted
- 30 May 2007 (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.
The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis being treated with drugs called atypical antipsychotics to determine the effects of the drugs on growth, weight gain, and laboratory tests.
Detailed description
Introduction: Antipsychotics have been used for many years to treat serious mental illnesses like schizophrenia and bipolar illness (manic depression). These older drugs carry a higher risk of side effects like shaking, stiffness, restlessness or uncontrolled movements. They may occur when the drugs are first taken, or later, after years of use. Newer drugs called atypical antipsychotics (ATA's) are much less likely to cause these problems. Their lack of these side effects and greater safety have led doctors to use them for other diseases in both adults and younger patients. They have proved to be helpful in aggression, impulsiveness, anxiety and mood swings. Unfortunately, a number of other side effects, such as weight gain, increased rates of diabetes and increases in cholesterol have also been identified. While a lot of current research into these side effects has been done in adults, there have been few studies with younger patients. The research so far has been brief and involved small numbers. This is especially important in this young and potentially vulnerable group of patients.
Study Methods: This research will study children and teens aged 6 to 18 who are being treated with the newer drugs for the first time. If agreeable to the patients and their parents or guardians, their doctors will prescribe one of the newer drugs and will measure the effects, if any, on weight, blood sugar, cholesterol as well as the improvement in their condition. Weight, height, and blood work will be done before the drug is started, and 6 and 12 months after they have been on it, comparing the results with their original values. The doctor, the patient and the parent or guardian will rate the patients' condition at these times, as well, to evaluate their improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Community sample of youth 6-18 where treatment with atypical antipsychotic medication is being initiated
Key inclusion criteria (9 listed)
- Atypical Antipsychotic naive patients who have agreed to take Atypical Antipsychotic medication upon the recommendation of their physician based on the child and their symptoms as per their usual patient care
- Outpatients and inpatients
- A wide range of patients including those with ADHD, Tourette's disorder, anxiety, disruptive behavior and mood instability as well as psychosis
- Children and adolescents aged 6 through 18 years
- Both sexes
Key exclusion criteria (4 listed)
- Patients with eating disorders (this condition might affect the expected weight and metabolic changes anticipated with the medications)
- Concurrent medical conditions including diabetes or hyperlipidemia if, in the judgment of the treating physician, the use of atypical anti-psychotics would be contra-indicated. (patient safety)
- Substance abuse (may effect the reliability of the patients or confound weight or metabolic effects of the medications)
- Pregnant or lactating patients (patient safety)
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
Increase in BMI
Time frame: 12 months
1 secondary outcome
Change in glucose and lipids
Time frame: 12 months
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 28 Aug 2017.
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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.
Tamison M Doey, MD FRCPC principal investigator
The University of Western Ontario
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effects, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites 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 9 inclusion and 4 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Increase in BMI (time frame: 12 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 28 Aug 2017.