Clinical trial NCT01269710: Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Official title: Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Second Generation Antipsychotics
Schizophrenia
Schizoaffective
Schizophreniform
Psychosis NOS
Mood Disorders
Weight
Autism
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.).

Primary outcomes:
measure: Change in Weight (in Lbs.)
timeFrame: Baseline and 52 Weeks
Secondary outcomes:
measure: Change in Glucose Levels (mg/dL)
timeFrame: Baseline and 52 Weeks
measure: Change in Total Cholesterol (mg/dL)
timeFrame: Baseline and 52 Weeks
measure: Change in Triglycerides (mg/dL)
timeFrame: Baseline and 52 Weeks
measure: Change in LDL (mg/dL)
timeFrame: Baseline and 52 Weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
References: