Adherence in Adolescents and Children Treated on Quetiapine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00680888

Enrollment

Registered

2008-05-20

Start date

2005-08-31

Completion date

2008-08-31

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

Keywords

Psychosis, adolescents, adherence, quetiapine

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival analysis of rate of adherence to treatment on quetiapine	6 months

Secondary

Measure	Time frame
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

Outcome results