ClinicalTrials.gov
ClinicalTrials.gov Menu

Antipsychotic Polypharmacy: Prevalence, Background and Consequences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00541398
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : November 2, 2009
Sponsor:
Collaborator:
National Board of Health, Denmark
Information provided by:
Glostrup University Hospital, Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Implementation of guideline Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Behavioral: Implementation of guideline
Outreach visits with interactive education for health staff
No Intervention: B



Primary Outcome Measures :
  1. Prevalence of antipsychotic polypharmacy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis. [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541398


Locations
Denmark
CNSR
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
National Board of Health, Denmark
Investigators
Study Director: Birte Glenthøj, Professor University of Copenhagen

Responsible Party: Professor Birte Glenthøj, Center for Neuropsychiatric Schizophrenia Research
ClinicalTrials.gov Identifier: NCT00541398     History of Changes
Other Study ID Numbers: 0-204-03-9-9
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Glostrup University Hospital, Copenhagen:
Antipsychotic polypharmacy
Schizophrenia
Implementation of clinical guidelines

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs