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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.
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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators aim to recruit 200 individuals between the ages of 3 and 19, from a diverse range of ethnic and racial backgrounds, who have a clinical diagnosis of psychotic disorders, mood disorder or an autism spectrum disorder and are considered for treatment with second generation antipsychotic (SGAP) medication by a physician.
Every effort will be made to recruit participants of all ethnicities, races and genders. The investigators will specifically target recruitment efforts toward minorities by using minority media and informational liaison with community organizations that serve minority populations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
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.
Subjects will be recruited from outpatient child psychiatry programs (including community clinics, school based mental health programs, private practices), inpatient psychiatry units and community outreach efforts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observed Treatment Group | Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician. Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12. All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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fasting glucose, lipid profile, insulin, leptin, prolactin, AST, ALT, CRP, adiponectin, ghrelin, cortisol, and relevant cytokines or peptide hormones (e.g., NP-Y, resistin, TNF-alpha, IL-1b, IL-2, IL-6, IL-8, IL-12, IL-18), sex hormones (e.g., testosterone, dehydroepiandrosterone, estrogen, luteinizing hormone, follicle stimulating hormone, and sex hormone binding globulin), and SGAP level (not baseline), to assure compliance. TSH and CBC will be measured at baseline only.
Each subject will be asked to provide an additional 16 ml blood sample (approximately 1 tablespoon) for DNA collection and genotyping.
| 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 |
| Week 12 |
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| Week 36 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observed Treatment Group | Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician. Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12. All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All four enrolled study participants were included in this analysis. | Posted | Mean | Standard Deviation | lbs. | Baseline and 52 Weeks |
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| Secondary | 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. | All four enrolled study participants were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 52 Weeks |
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| Secondary | 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. | All four enrolled study participants were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 52 Weeks |
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| Secondary | 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. | All four enrolled study participants were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 52 Weeks |
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| Secondary | 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. | All four enrolled study participants were included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 52 Weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observed Treatment Group | Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician. Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12. All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks. | 0 | 4 | 0 | 4 |
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This study only enrolled 4 subjects, thus, sample size was a significant limitation. Further, since only a single subject completed to Week 52, it is difficult to determine treatment indication effectiveness with second generation antipsychotics.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linmarie Sikich, M.D. | The University of North Carolina at Chapel Hill | (919) 972-7499 | lsikich@med.unc.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D012569 | Schizotypal Personality Disorder |
| D019964 | Mood Disorders |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| D000067877 | Autism Spectrum Disorder |
| D001523 | Mental Disorders |
| D001835 | Body Weight |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D010554 | Personality Disorders |
| D000068105 | Bipolar and Related Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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