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
  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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   3 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269710

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
  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:
Bipolar Disorder
Child Development Disorders, Pervasive
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia
Schizotypal Personality Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Personality Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014