A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00480168
First received: May 25, 2007
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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.


Condition
Adverse Effects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Assess Metabolic Changes in Children and Adolescents Aged 6-18 Treated With Atypical Antipsychotics

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Increase in BMI [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glucose and lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2007
Estimated Study Completion Date: August 2011
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample of youth 6-18 where treatment with atypical antipsychotic medication is being initiated

Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480168

Contacts
Contact: Tamison M Doey, MD FRCPC 519 258 0484 ext 138 drtamison@yahoo.com
Contact: Brenda Davidson 519 685 8500 ext 77130 brenda.davidson@lhsc.on.ca

Locations
Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada
Contact: Brenda Davidson    519 685 8500 ext 77130    brenda_davidson@lhsc.on.ca   
Contact: Margaret Steele, MD FRCPC    519 685 8500 ext 77130    margaret_steele@lhsc.on.ca   
Sub-Investigator: Margaret Steele, MD FRCPC         
Windsor Regional Hospital Recruiting
Windsor, Ontario, Canada, N8W 1L9
Contact: Tamison M Doey, MD FRCPC    519 258 0484 ext 138    drtamison@yahoo.com   
Principal Investigator: Tamison Doey, MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Tamison M Doey, MD FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Tamison Doey MD FRCPC, The University of Western Ontario
ClinicalTrials.gov Identifier: NCT00480168     History of Changes
Other Study ID Numbers: R-05-116, 11172
Study First Received: May 25, 2007
Last Updated: March 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
child
adolescent
weight gain
endocrine disruptors

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014