N/A
N=4
Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder · Psychotic Disorder, Not Otherwise Specified · Prodromal Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01269710 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Change in Weight (in Lbs.) — 24.9 lbs.
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight (in Lbs.) |
24.9 | — |
| SECONDARY Change in Glucose Levels (mg/dL) |
-2.25 | — |
| SECONDARY Change in Total Cholesterol (mg/dL) |
-8.75 | — |
| SECONDARY Change in Triglycerides (mg/dL) |
18.75 | — |
| SECONDARY Change in LDL (mg/dL) |
-6.25 | — |
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.
Eligibility Criteria
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.).
Data sourced from ClinicalTrials.gov (NCT01269710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.