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Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine

NCT00617058 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-12-31

Study results available
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Summary

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):

* Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;
* Add the diabetes drug, metformin + continuation of current SGA.

Conditions

  • Weight Gain

Interventions

DRUG

metformin

open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID

BEHAVIORAL

healthy lifestyle intervention

additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.

Sponsors & Collaborators

  • Foundation of Hope, North Carolina

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Linmarie Sikich, MD · University of North Carolina, Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617058 on ClinicalTrials.gov