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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge Health Alliance
• Collaborator: American Psychiatric Association
• Treatments: Antipsychotic Agents; Metformin

Criteria

Inclusion Criteria:

1. Males and females aged 10-18 years.

2. A DSM-IV diagnosis of bipolar disorder schizophrenia spectrum disorder, or pervasive developmental disorder.

3. Ability to give assent.

4. 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.

5. On stable dose of quetiapine, olanzapine, or risperidone x2 weeks.

6. Otherwise medically stable.

Exclusion Criteria:

1. Subjects meeting criteria for an eating disorder or an autistic spectrum disorder.

2. 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.

3. 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.

4. Subjects taking antidepressants.

5. Active substance abuse/dependence based upon history and/or urine toxicology tests performed at screening.

6. Inability to have blood drawn at baseline, weekly, and termination visits.

7. Known allergy or hypersensitivity to metformin or its ingredients.

8. Recent history of suicidality, suicidal ideation, or suicide attempts.

9. Patients clinically unstable on current medication regimen.