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Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth (PREVENT)

Primary Purpose

Weight Gain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

metformin

placebo

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring antipsychotic, metformin, children, adolescents

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

metformin in doses from 250mg to 2000mg/day for 26 weeks

Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day

Outcomes

Primary Outcome Measures

Change From Baseline to Week 24 in Body Mass Index (BMI)

Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.

Change From Baseline to Week 24 in Weight

Change in weight is calculated as 24 weeks weight minus the baseline weight.

Change From Baseline to Week 24 in Fat Mass

Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.

Secondary Outcome Measures

Change From Baseline to Week 24 in Insulin Level

Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.

Change From Baseline to Week 24 in Cholesterol Level

According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.

Change From Baseline to Week 24 in Triglycerides

In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.

Incidence of Metabolic Syndrome

Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.

Full Information

NCT ID

NCT00617240

First Posted

February 5, 2008

Last Updated

February 7, 2014

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation of Hope, North Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00617240

Brief Title

Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

Acronym

PREVENT

Official Title

Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation of Hope, North Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Gain

Keywords

antipsychotic, metformin, children, adolescents

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

metformin in doses from 250mg to 2000mg/day for 26 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day

Intervention Type

Drug

Intervention Name(s)

metformin

Other Intervention Name(s)

Glucophage

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline to Week 24 in Body Mass Index (BMI)

Description

Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.

Time Frame

0-24 weeks

Title

Change From Baseline to Week 24 in Weight

Description

Change in weight is calculated as 24 weeks weight minus the baseline weight.

Time Frame

24 weeks

Title

Change From Baseline to Week 24 in Fat Mass

Description

Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 24 in Insulin Level

Description

Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.

Time Frame

24 weeks

Title

Change From Baseline to Week 24 in Cholesterol Level

Description

Time Frame

24 weeks

Title

Change From Baseline to Week 24 in Triglycerides

Description

Time Frame

24 weeks

Title

Incidence of Metabolic Syndrome

Description

Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linmarie Sikich, MD

Organizational Affiliation

Unversity of North Carolina, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina, Department of Psychiatry

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

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Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

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