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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
  Purpose

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


Condition
Psychosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Adherence in Adolescents and Children Treated on Quetiapine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Survival analysis of rate of adherence to treatment on quetiapine [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: JAVIER JIMENEZ / MEDICAL DIRECTOR, AstraZeneca Pharmaceuticals Spain S.A
ClinicalTrials.gov Identifier: NCT00680888     History of Changes
Other Study ID Numbers: NIS-NES-SER-2006/1
Study First Received: May 16, 2008
Last Updated: December 7, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Psychosis
adolescents
adherence
quetiapine

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013