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

Schizophrenia Clinical Trial

— SATIETY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269710
• Other study ID #: 09-1734
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 18, 2013
• Start date: October 2009
• Est. completion date: March 2011

Study information

• Verified date: January 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 19 Years

Eligibility

Inclusion Criteria:

1. Patients between the ages of 3 and 19 (at the time of consent)

2. 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.

3. Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her

4. 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:

1. Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)

2. Personal history of or comorbid eating disorders

3. Active hyper-/hypothyroidism

4. Pregnancy

5. Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Bipolar Disorder
• Child Development Disorders, Pervasive
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Not Otherwise Specified
• Disease
• Major Depressive Disorder
• Mental Disorders
• Mood Disorder
• Mood Disorder, Not Otherwise Specified
• Mood Disorders
• Prodromal Schizophrenia
• Psychotic Disorder, Not Otherwise Specified
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder
• Schizotypal Personality Disorder

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 52 Weeks	No
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.	Baseline and 52 Weeks	No
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.	Baseline and 52 Weeks	No
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.	Baseline and 52 Weeks	No
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.	Baseline and 52 Weeks	No