Adherence in Adolescents and Children Treated on Quetiapine

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00680888

First received: May 16, 2008

Last updated: December 7, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 16, 2008
Last Updated Date	December 7, 2010
Start Date ^ICMJE	August 2005
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2008)	Survival analysis of rate of adherence to treatment on quetiapine [ Time Frame: 6 months ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00680888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 16, 2008)	Survival analysis of rate of adherence to treatment on quetiapine [ Time Frame: 12 months ] Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence [ Time Frame: 0, 6, 12 months ] Tolerability profile (UKU) possibly influencing adherence [ Time Frame: 0, 6, 12 months ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Adherence in Adolescents and Children Treated on Quetiapine
Official Title ^ICMJE	Adherence in Adolescents and Children Treated on 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
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006
Condition ^ICMJE	Psychosis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	August 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	7 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00680888
Other Study ID Numbers ^ICMJE	NIS-NES-SER-2006/1
Has Data Monitoring Committee	No
Responsible Party	JAVIER JIMENEZ / MEDICAL DIRECTOR, AstraZeneca Pharmaceuticals Spain S.A
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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