Adherence in Adolescents and Children Treated on Quetiapine

Completed

• Conditions: Psychosis

• Registration Number: NCT00680888
• Lead Sponsor: AstraZeneca

Brief Summary

Observational study aimed to describe the adherence in a population of adolescents and children treated on quetiapine from a first psychotic episode whose more important secondary objective is to identify possible predictive factors influencing the adherence to treatment with Quetiapine

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• At least one psychotic symptom (delusions or hallucinations) before age 18.
• Start of treatment in a maximum period of 2 years after the onset of first psychotic symptom
• Written informed consent by parents or guardians and patients.

Exclusion Criteria

• Pregnancy or lactancy
• High risk of aggression or suicidal behaviour
• Alcohol dependence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival analysis of rate of adherence to treatment on quetiapine	6 months

Secondary Outcome Measures

Name	Time	Method
Survival analysis of rate of adherence to treatment on quetiapine	12 months
Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence	0, 6, 12 months
Tolerability profile (UKU) possibly influencing adherence	0, 6, 12 months