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

NCT01269710 | Completed Results

• 1 other identifier: 09-1734
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Weight (in Lbs.)

  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.

  Baseline and 52 Weeks

Secondary Outcomes (4)

• Change in Glucose Levels (mg/dL)

  Baseline and 52 Weeks

• Change in Total Cholesterol (mg/dL)

  Baseline and 52 Weeks

• Change in Triglycerides (mg/dL)

  Baseline and 52 Weeks

• Change in LDL (mg/dL)

  Baseline and 52 Weeks

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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.).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fasting glucose, lipid profile, insulin, leptin, prolactin, AST, ALT, CRP, adiponectin, ghrelin, cortisol, and relevant cytokines or peptide hormones (e.g., NP-Y, resistin, TNF-alpha, IL-1b, IL-2, IL-6, IL-8, IL-12, IL-18), sex hormones (e.g., testosterone, dehydroepiandrosterone, estrogen, luteinizing hormone, follicle stimulating hormone, and sex hormone binding globulin), and SGAP level (not baseline), to assure compliance. TSH and CBC will be measured at baseline only. Each subject will be asked to provide an additional 16 ml blood sample (approximately 1 tablespoon) for DNA collection and genotyping.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizotypal Personality Disorder; Mood Disorders; Bipolar Disorder; Depressive Disorder, Major; Depressive Disorder; Autism Spectrum Disorder; Mental Disorders; Body Weight; Autistic Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Personality Disorders; Bipolar and Related Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study only enrolled 4 subjects, thus, sample size was a significant limitation. Further, since only a single subject completed to Week 52, it is difficult to determine treatment indication effectiveness with second generation antipsychotics.

Results Point of Contact

• Title: Linmarie Sikich, M.D.
• Organization: The University of North Carolina at Chapel Hill

lsikich@med.unc.edu

(919) 972-7499

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: October 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 22, 2013
• Results First Posted: February 22, 2013

Record last verified: 2013-01

Locations

US (1)