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CompletedNCT00680888Updated Dec 9, 2010

Adherence in Adolescents and Children Treated on Quetiapine

An observational study in Psychosis, sponsored by AstraZeneca. Completed. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2010-12-09.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
7 Years to 17 Years
Sex
All
01

Study 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

02

Conditions studied

  • Psychosis

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Keywords

  • Psychosis
  • adolescents
  • adherence
  • quetiapine
03

In context

Psychotic Disorders

1,655 studies on the registry are indexed under Psychotic Disorders; 298 are open to participants now.

This study's enrollment of 30 is below the median of 150 across 248 observational studies indexed under Psychotic Disorders.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy or lactancy
  • High risk of aggression or suicidal behaviour
  • Alcohol dependence
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (actual)

Groups and cohorts

  • 1

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2005, a primary completion of Aug 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2008
First posted
May 20, 2008
Start
Aug 2005
Primary completionActual
Aug 2008
CompletionActual
Aug 2008
Last update
Dec 9, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00680888
Lead sponsor
AstraZeneca
First posted
May 20, 2008
Start date
Aug 2005
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Dec 9, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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