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Completed

NCT Number: NCT00680888

Adherence in Adolescents and Children Treated on Quetiapine

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

Completed

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival analysis of rate of adherence to treatment on quetiapine

    Time frame: 6 months

Secondary outcomes

  1. Survival analysis of rate of adherence to treatment on quetiapine

    Time frame: 12 months

  2. Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence

    Time frame: 0, 6, 12 months

  3. Tolerability profile (UKU) possibly influencing adherence

    Time frame: 0, 6, 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 20, 2008
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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