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

Completed

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01269710

Run by

University of North Carolina, Chapel Hill

People needed

4

Starts

2009-10-01

Expected to finish

2011-03-01

Last updated by the study team

2013-02-22

Who can join

Age: 3 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.).

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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