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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effects

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Science Centre
    • Windsor, Ontario, Canada, N8W 1L9
      • Windsor Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in BMI	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in glucose and lipids	12 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Tamison M Doey, MD FRCPC, The University of Western Ontario

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2005
• Primary Completion (Actual): August 31, 2012
• Study Completion (Actual): August 31, 2012

Study Registration Dates

• First Submitted: May 25, 2007
• First Submitted That Met QC Criteria: May 25, 2007
• First Posted (Estimate): May 30, 2007

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: adolescent; child; weight gain; endocrine disruptors
• Other Study ID Numbers: R-05-116; 11172 (REB)