An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medica… (NCT00391261) | Clinical Trial Compass
CompletedPhase 4
An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.
United States11 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.