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Completed

NCT Number: NCT01269710

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

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.

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Key information

Conditions

Schizophrenia Autism Spectrum Disorder Autistic Disorder Bipolar Disorder Bipolar and Related Disorders Body Weight Child Development Disorders, Pervasive Depressive Disorder Depressive Disorder, Major Depressive Disorder, Not Otherwise Specified Major Depressive Disorder Mental Disorders Mood Disorder Mood Disorder, Not Otherwise Specified Mood Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Personality Disorders Prodromal Schizophrenia Psychotic Disorder, Not Otherwise Specified Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorder Schizotypal Personality Disorder Signs and Symptoms

Age range

3 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. Change in Weight (in Lbs.)

    Time frame: Baseline and 52 Weeks

    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 outcomes

  1. Change in Glucose Levels (mg/dL)

    Time frame: Baseline and 52 Weeks

    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.

  2. Change in Total Cholesterol (mg/dL)

    Time frame: Baseline and 52 Weeks

    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.

  3. Change in Triglycerides (mg/dL)

    Time frame: Baseline and 52 Weeks

    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.

  4. Change in LDL (mg/dL)

    Time frame: Baseline and 52 Weeks

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: SATIETY

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 4, 2011
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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