Eligibility screening information | Exclusion criteria |
---|---|
Current medication regimen* | 1. Any medication that would significantly alter glucose, insulin, or lipid levels. |
2. Treatment with >1 antipsychotic medication. | |
3. Treatment with >3 total psychiatric medications (exception: 4 total permitted if 2 are ADHD drugs) | |
Screening labs** | 4. Fasting glucose >125 mg/dL |
5. Positive urine toxicology screen | |
6. Serum creatinine ≥ 1.3 mg/dL | |
7. Independent pediatric consultation is required if glucose 100-125 mg/dL; triglycerides >300 mg/dL, total cholesterol >300 mg/dL, ALT>174 or 3X upper limit normal to determine if study participation is appropriate | |
Somatic health conditions*** | 8. Any major neurological or medical illness that affects weight, requires a prohibited systemic medication, or prohibits physical activity/use of AMA weight loss guidelines. |
Psychiatric diagnosis | 9. Substance dependence disorder (except tobacco dependence) in the past month |
10. Current or lifetime diagnosis of anorexia nervosa or bulimia nervosa | |
11. IQ <55 | |
Medication history | 12. Known hypersensitivity to aripiprazole, perphenazine, or metformin |
13. Prior trials of aripiprazole and perphenzine that were >2 weeks and stopped because of efficacy or tolerability concerns | |
14. Psychiatric medication or dosage change within the past 30 days. | |
Additional safety concerns | 15. Significant risk of dangerousness to self or others |
16. Ongoing or previously undisclosed child abuse requiring new social service intervention. | |
Caregiver considerations | 17. Caregiver unable to participate in assessments or has not known child at least 6 months |
18. Caregiver or child have language issue that makes them unable to complete assessments | |
Female participants | 19. Pregnant, nursing, or sexually active and unwilling to comply with double method contraceptive |