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Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

NCT00617240 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-03-11

Study results available
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Summary

The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.

Conditions

  • Weight Gain

Interventions

DRUG

metformin

500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks

DRUG

placebo

500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks

Sponsors & Collaborators

  • Foundation of Hope, North Carolina

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT00617240 on ClinicalTrials.gov