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

NCT ID: NCT01269710

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-03-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Linmarie Sikich, MD

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

09-1734

Identifier Type: -

Identifier Source: org_study_id