Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

NCT00617240 | Completed Phase 2 Results

• 1 other identifier: 05-2992 GCRC-2501
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Keywords

antipsychotic; metformin; children; adolescents

Outcome Measures

Primary Outcomes (3)

• 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.

  0-24 weeks

• Change From Baseline to Week 24 in Weight

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

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (4)

• Change From Baseline to Week 24 in Insulin Level

  24 weeks

• Change From Baseline to Week 24 in Cholesterol Level

  24 weeks

• Change From Baseline to Week 24 in Triglycerides

  24 weeks

• Incidence of Metabolic Syndrome

  24 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: metformin

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

metformin DRUG

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

Also known as: Glucophage

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

University of North Carolina, Department of Psychiatry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Weight Gain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Small number of subjects analyzed and recruited, however, based on preliminary data, a larger, multi-site trial was developed.

Results Point of Contact

• Title: Linmarie Sikich, MD
• Organization: The University of North Carolina at Chapel Hill

lsikich@med.unc.edu

(919) 972-7500

Study Officials

• Linmarie Sikich, MD

  Unversity of North Carolina, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: January 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-02

Locations

US (1)