PsychosisNCT00680888
Adherence in Adolescents and Children Treated on Quetiapine
An observational study of Psychosis, run by AstraZeneca.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Psychosis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactancy
- High risk of aggression or suicidal behaviour
- Alcohol dependence
About this study
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
- Conditions
- Psychosis
- Keywords
- Psychosis, adolescents, adherence, quetiapine
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis of rate of adherence to treatment on quetiapine
Measured: 6 months
Secondary outcomes (3)
Survival analysis of rate of adherence to treatment on quetiapine
Measured: 12 months
Clinical and sociodemographic parameters (CGI-C, CGI-Suicidal, PANSS, HDRS, YMRS, SDQ, DAS, GAF, SUMD) possibly influencing adherence
Measured: 0, 6, 12 months
Tolerability profile (UKU) possibly influencing adherence
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startAug 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680888
- Sponsor's protocol ID
- NIS-NES-SER-2006/1
- Status last verified
- Dec 2010
- First submitted
- 16 May 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence in Adolescents and Children Treated on Quetiapine
- ClinicalTrials.gov ID
- NCT00680888
- Acronym / sponsor ID
- NIS-NES-SER-2006/1
- Conditions
- Psychosis
- Keywords
- Psychosis, adolescents, adherence, quetiapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006 |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents with psychosis in outpatients setting on treatment with quetiapine started from january 2003 to june 2006
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy or lactancy
- High risk of aggression or suicidal behaviour
- Alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival analysis of rate of adherence to treatment on quetiapine
Time frame: 6 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival analysis of rate of adherence to treatment on quetiapine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.