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Table 3 Exclusion criteria

From: Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

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
  1. *Antipsychotic medication, stimulant medication, and divalproex sodium are permitted. Prohibited medications include, but are not limited to: insulin, systemic steroids, topiramate, sibutramine, orlistat, metformin, amantadine, vitamin E (other than in standard multivitamins), statins, and anti-hypertensive medication. Exception: orlistat and amantadine are permitted if taken for >1 year without weight loss.
  2. **Laboratory tests are repeated for confirmation if they are abnormal.
  3. ***Medical conditions that lead to exclusion include, but are not limited to, diabetes, unstable thyroid disease, chronic renal failure.