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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 3 and 19 (at the time of consent) Clinical diagnosis of psychotic disorders (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified and prodromal schizophrenia (as defined by the Scale of Prodromal Symptoms (SOPS: Miller 1996)), mood disorder (i.e., bipolar disorder, major depressive disorder, depressive disorder not otherwise specified, mood disorder not otherwise specified) or an autism spectrum disorder. Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her Subjects who are either A) antipsychotic naïve and have started an SGA within the past 2 weeks , B) have started a new antipsychotic within the past 2 weeks (specifically within 2 weeks of their first blood draw), or Exclusion Criteria: Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent) Personal history of or comorbid eating disorders Active hyper-/hypothyroidism Pregnancy Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight (in Lbs.) | 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. | Baseline and 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glucose Levels (mg/dL) | 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. | Baseline and 52 Weeks | 
| Change in Total Cholesterol (mg/dL) | 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. | Baseline and 52 Weeks | 
| Change in Triglycerides (mg/dL) | 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. | Baseline and 52 Weeks | 
| Change in LDL (mg/dL) | 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. | Baseline and 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Second Generation Antipsychotics, Schizophrenia, Schizoaffective, Schizophreniform, Psychosis NOS, Mood Disorders, Weight, Autism