NCT00680888

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

3 years

First QC Date

May 16, 2008

Last Update Submit

December 7, 2010

Conditions

Psychosis

Keywords

Psychosisadolescentsadherencequetiapine

Outcome Measures

Primary Outcomes (1)

  • Survival analysis of rate of adherence to treatment on quetiapine

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

1

Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or lactancy
  • High risk of aggression or suicidal behaviour
  • Alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

August 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 9, 2010

Record last verified: 2010-12