Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT00391261
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT00391261
Study Brief:
Protocol Section:
NCT00391261