Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study (SATIETY)
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Purpose
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.
| Condition |
|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study |
- Change in Weight (in Lbs.) [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
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 Glucose Levels (mg/dL) [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: Samples Without DNA
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.
| Enrollment: | 4 |
| Study Start Date: | October 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 3 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01269710 History of Changes |
| Other Study ID Numbers: | 09-1734 |
| Study First Received: | January 3, 2011 |
| Results First Received: | November 8, 2012 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Second Generation Antipsychotics Schizophrenia Schizoaffective Schizophreniform |
Psychosis NOS Mood Disorders Weight Autism |
Additional relevant MeSH terms:
|
Autistic Disorder Bipolar Disorder Depressive Disorder Depression Schizotypal Personality Disorder Psychotic Disorders Mental Disorders Schizophrenia Depressive Disorder, Major Mood Disorders Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood |
Affective Disorders, Psychotic Behavioral Symptoms Personality Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013