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NCT00680888 Clinical Trial

Adherence in Adolescents and Children Treated on Quetiapine

Psychosis Clinical Trial

Official title:
Adherence in Adolescents and Children Treated on Quetiapine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00680888
Other study ID # NIS-NES-SER-2006/1
Secondary ID
Status Completed
Phase N/A
First received May 16, 2008
Last updated December 7, 2010
Start date August 2005
Est. completion date August 2008

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Survival analysis of rate of adherence to treatment on quetiapine 6 months
Secondary Survival analysis of rate of adherence to treatment on quetiapine 12 months
Secondary Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence 0, 6, 12 months
Secondary Tolerability profile (UKU) possibly influencing adherence 0, 6, 12 months
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