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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Linmarie Sikich, MD, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01269710

First received: January 3, 2011

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 3, 2011
Last Updated Date	January 18, 2013
Start Date ^ICMJE	October 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2013)	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.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01269710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 18, 2013)	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.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Official Title ^ICMJE	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 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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: 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.
Sampling Method	Non-Probability Sample
Study Population	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.
Condition ^ICMJE	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
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	4
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.).
Gender	Both
Ages	3 Years to 19 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01269710
Other Study ID Numbers ^ICMJE	09-1734
Has Data Monitoring Committee	No
Responsible Party	Linmarie Sikich, MD, University of North Carolina, Chapel Hill
Study Sponsor ^ICMJE	University of North Carolina, Chapel Hill
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of North Carolina, Chapel Hill
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top