Status:
COMPLETED
An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
American Psychiatric Association
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
10-18 years
Phase:
PHASE4
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 antipsychoti...
Detailed Description
Patients taking olanzapine, risperidone, or quetiapine with increased BMI of at least 10% over the previous 2 months of atypical therapy will be eligible for the study. Subjects will need to have been...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00391261
Start Date
July 1 2006
End Date
October 1 2007
Last Update
March 25 2010
Active Locations (1)
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1
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155