An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.

NCT00391261 | Completed Phase 4

• 1 other identifier: CHA-IRB-0143/12/05
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight control and/or weight loss. We hypothesize that metformin would prevent further weight gain or lead to weight loss, resulting in amelioration of one of the most significant side effects of atypical antipsychotic use.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar Disorder; Autism Spectrum Disorders

Keywords

weight gain; obesity; metabolism

Outcome Measures

Primary Outcomes (1)

• BMI

  weekly

Secondary Outcomes (1)

• MOSES

  weekly

Interventions

Metformin DRUG

open-label, flexible dosing

Also known as: Glucophage

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females aged 10-18 years.
• A DSM-IV diagnosis of bipolar disorder schizophrenia spectrum disorder, or pervasive developmental disorder.
• Ability to give assent.
• At least 10% increase in body mass index (BMI) within the past 2 months of quetiapine, olanzapine, or risperidone treatment, per parent or physician report.
• On stable dose of quetiapine, olanzapine, or risperidone x2 weeks.
• Otherwise medically stable.

You may not qualify if:

• Subjects meeting criteria for an eating disorder or an autistic spectrum disorder.
• IQ below the mild mental retardation range (\<60), based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated based on current classroom placement.
• Significant medical and/or neurological illness, including seizure disorders, severe respiratory illness or cardiac conditions; cerebrovascular disease; hypo- or hypertension; immune, endocrine, renal, or hepatic dysfunction. The definition of such dysfunction will be derived from laboratory normal ranges, such that values lying outside those ranges would be considered abnormal.
• Subjects taking antidepressants.
• Active substance abuse/dependence based upon history and/or urine toxicology tests performed at screening.
• Inability to have blood drawn at baseline, weekly, and termination visits.
• Known allergy or hypersensitivity to metformin or its ingredients.
• Recent history of suicidality, suicidal ideation, or suicide attempts.
• Patients clinically unstable on current medication regimen.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• American Psychiatric Association: collaborator

Study Sites (1)

Cambridge Health Alliance

Medford, Massachusetts, 02155, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Autism Spectrum Disorder; Weight Gain; Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jean A Frazier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 25, 2010

Record last verified: 2008-06

Locations

US (1)