NCT01269710

Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 3 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.

Detailed description

Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4 visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study does not involve treatment for participants. Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study. All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder
• Psychotic Disorder, Not Otherwise Specified
• Prodromal Schizophrenia
• Mood Disorder
• Bipolar Disorder
• Major Depressive Disorder
• Depressive Disorder, Not Otherwise Specified
• Mood Disorder, Not Otherwise Specified
• Autism Spectrum Disorder

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-01-04
• Last updated: 2013-02-22
• Results posted: 2013-02-22

Locations

1 site across 1 country: United States