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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 Summary:

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.

Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change in Weight (in Lbs.) [ Time Frame: Baseline and 52 Weeks ]

Original Primary Outcome:

Current Secondary Outcome:

• Change in Glucose Levels (mg/dL) [ Time Frame: Baseline and 52 Weeks ]

  Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).

  Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.

• Change in Total Cholesterol (mg/dL) [ Time Frame: Baseline and 52 Weeks ]

  Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).

  Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.

• Change in Triglycerides (mg/dL) [ Time Frame: Baseline and 52 Weeks ]

  Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).

  Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.

• Change in LDL (mg/dL) [ Time Frame: Baseline and 52 Weeks ]

  Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).

  Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.

Original Secondary Outcome:

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: January 3, 2011
Date Started: October 2009
Date Completion:
Last Updated: January 18, 2013
Last Verified: January 2013