SchizophreniaNCT00541398
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
A study testing Implementation of guideline in people with Schizophrenia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Implementation of guideline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Oct 2009
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The intervention is not aimed directly to the patients but their health care providers.
- Patients with schizophrenia (F2* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
- The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.
Read the detailed description
Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant prescription of at least 2 different antipsychotics) among patients with schizophrenia even though international guidelines recommend monotherapy.
From register data areas with differences in the prevalence of antipsychotic polypharmacy will be identified. Two high prevalence areas will be randomized to either control or intervention area. In the intervention area an intensive educational intervention consisting of outreach visits with a multifaceted approach will be carried out with the duration of 1 year.
Differences in health staff related factors such as knowledge and attitude towards clinical guidelines will be assessed with a questionnaire before and after the intervention in the intervention area as well as in the low prevalence area at baseline.
Medical records data describing the use of antipsychotic polypharmacy will be collected. With register data health economic issues will be assessed.
- Conditions
- Schizophrenia
- Being tested
- Implementation of guideline
- Keywords
- Antipsychotic polypharmacy, Schizophrenia, Implementation of clinical guidelines
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of guidelineBehavioural
Outreach visits with interactive education for health staff
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Implementation of guideline |
| B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antipsychotic polypharmacy
Measured: 1 year
Secondary outcomes (1)
Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark
- Investigators
- Birte Glenthøj, Professor, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541398
- Sponsor's protocol ID
- 0-204-03-9-9
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2007
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipsychotic Polypharmacy: Prevalence, Background and Consequences
- ClinicalTrials.gov ID
- NCT00541398
- Acronym / sponsor ID
- 0-204-03-9-9
- Conditions
- Schizophrenia
- Keywords
- Antipsychotic polypharmacy, Schizophrenia, Implementation of clinical guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 10 Oct 2007 (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.
The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.
Detailed description
Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant prescription of at least 2 different antipsychotics) among patients with schizophrenia even though international guidelines recommend monotherapy.
From register data areas with differences in the prevalence of antipsychotic polypharmacy will be identified. Two high prevalence areas will be randomized to either control or intervention area. In the intervention area an intensive educational intervention consisting of outreach visits with a multifaceted approach will be carried out with the duration of 1 year.
Differences in health staff related factors such as knowledge and attitude towards clinical guidelines will be assessed with a questionnaire before and after the intervention in the intervention area as well as in the low prevalence area at baseline.
Medical records data describing the use of antipsychotic polypharmacy will be collected. With register data health economic issues will be assessed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Implementation of guideline |
| B | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The intervention is not aimed directly to the patients but their health care providers.
- Patients with schizophrenia (F2* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
- The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of guidelineOutreach visits with interactive education for health staff | Behavioural | A |
Primary outcome
Prevalence of antipsychotic polypharmacy
Time frame: 1 year
1 secondary outcome
Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.
Time frame: 1 year
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 2 Nov 2009.
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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.
Birte Glenthøj, Professor study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of guideline in people with Schizophrenia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 0 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 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Prevalence of antipsychotic polypharmacy (time frame: 1 year). 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 2 Nov 2009.