Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth - Full Text View

Sponsors and Collaborators:	University of North Carolina Foundation of Hope
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617240

Purpose

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.

Condition	Intervention	Phase
Weight Gain	Drug: metformin Drug: placebo	Phase II

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

BMI change [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
weight change [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
fat mass [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

change in insulin level [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
change in cholesterol level [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
change in triglycerides [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
incidence of metabolic syndrome [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental metformin in doses from 250mg to 2000mg/day for 26 weeks	Drug: metformin 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks
2: Placebo Comparator Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day	Drug: placebo 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks

Detailed Description:

This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.

The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity
Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders
SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone
Legal guardian able and willing to give written informed consent
If competent, subject able and willing to assent for their own participation

Exclusion Criteria:

Previous trial of metformin
Recommendation for treatment with clozapine or ziprasidone
Current use of insulin or any oral hypoglycemic agent
Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)
Any current or past diagnosis of an eating disorder
Diabetes mellitus
Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease
Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment.
Pregnancy or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617240

Contacts

Contact: Madeline Puglia, BA

1-800-708-0048

puglia@med.unc.edu

Locations

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: T. C. Bethea, MD

Sponsors and Collaborators

University of North Carolina

Foundation of Hope

Investigators

Principal Investigator:

Linmarie Sikich, MD

Unversity of North Carolina, Department of Psychiatry

More Information

No publications provided

Responsible Party:	UNC_ChapelHill ( Linmarie Sikich, MD )
Study ID Numbers:	05-2992 GCRC-2501
Study First Received:	February 5, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00617240 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of North Carolina, Chapel Hill:

antipsychotic
metformin
children
adolescents

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Tranquilizing Agents
Hypoglycemic Agents
Metformin

Psychotropic Drugs
Body Weight Changes
Central Nervous System Depressants
Antipsychotic Agents
Weight Gain

Additional relevant MeSH terms:

Tranquilizing Agents
Metformin
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Weight Gain
Antipsychotic Agents

Pharmacologic Actions
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Therapeutic Uses
Body Weight Changes
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009