Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of North Carolina Foundation of Hope |
---|---|
Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00617058 |
The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):
Condition | Intervention | Phase |
---|---|---|
Weight Gain |
Drug: metformin Behavioral: healthy lifestyle intervention Other: No intervention |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Metabolic Parameters of Antipsychotic Child Treatment |
Estimated Enrollment: | 60 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.
|
Drug: metformin
open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID
|
2: Experimental
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors
|
Behavioral: healthy lifestyle intervention
additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
|
3: No Intervention
Self selected patients will be followed at major timepoints to assess weight and related measures
|
Other: No intervention
patients who self select to continue on current meds without plan for behavioral or pharmacologic intervention. Such patients will receive majoy assessments at same timepoint as other subjects.
|
The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks and benefits of three approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA). The critical question being addressed is: What can be done for the many youth who have gained substantial weight or developed high levels of lipids or glucose in their blood on an SGA; but due to their illness require continued treatment with an antipsychotic?
At least 40 youths (and no more than 60) age 10-17 that have gained substantial weight while taking one of the three most frequently used SGAs; olanzapine, risperidone, quetiapine, aripiprazole or ziprasidone will be randomized to one of two treatments for 6 months:
Height, weight, body fat, and various blood tests indicative of general health will be collected during the 6 month trial to monitor the health benefits and safety of the interventions.
SGAs are associated with concerning degrees of weight gain and metabolic consequences. Children and adolescents, in whom SGAs are used increasingly for a wide variety of conditions, are particularly vulnerable to these side effects, which adversely affect health and longevity. It is imperative that researchers evaluate the efficacy and safety of interventions designed to prevent and treat the weight gain and metabolic problems caused by antipsychotic treatment of children. Lifestyle interventions and adjunctive medications all hold some promise of efficacy. However, it is essential that these strategies be rigorously evaluated as soon as possible in order to prevent the ongoing health consequences of SGA treatment in another generation of children with serious psychiatric illnesses.
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Madeline Puglia, BA | 919-966-6774 | puglia@med.unc.edu |
United States, North Carolina | |
University of North Carolina, Department of Psychiatry | Recruiting |
Chapel HIll, North Carolina, United States, 27599 | |
Principal Investigator: Linmarie Sikich, MD | |
Sub-Investigator: Denisse Ambler, MD | |
Sub-Investigator: TC Bethea, MD |
Principal Investigator: | Linmarie Sikich, MD | University of North Carolina, Department of Psychiatry |
Responsible Party: | UNC_ChapelHill ( Linmarie Sikich, MD ) |
Study ID Numbers: | 05-3110 GCRC-2529 |
Study First Received: | February 5, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00617058 |
Health Authority: | United States: Food and Drug Administration |
antipsychotic metformin children adolescents |
Body Weight Signs and Symptoms Metformin Body Weight Changes Weight Gain |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |