Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)
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ClinicalTrials.gov Identifier: NCT00594269 |
Recruitment Status
:
Completed
First Posted
: January 15, 2008
Last Update Posted
: February 23, 2011
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 3, 2008 | ||||||
First Posted Date ICMJE | January 15, 2008 | ||||||
Last Update Posted Date | February 23, 2011 | ||||||
Study Start Date ICMJE | August 2008 | ||||||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00594269 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Dementia Antipsychotics And Antidepressants Discontinuation Study | ||||||
Official Title ICMJE | Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT. | ||||||
Brief Summary | The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD). | ||||||
Detailed Description | Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is used as treatment, despite its lack of clinical evidence. We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes. This is a double blind RCT study with placebo-controlled group. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Dementia | ||||||
Intervention ICMJE |
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Study Arms | Placebo Comparator: A
Discontinuation of antipsychotic or antidepressants
Interventions:
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Publications * | Bergh S, Selbæk G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012 Mar 9;344:e1566. doi: 10.1136/bmj.e1566. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
149 | ||||||
Original Estimated Enrollment ICMJE |
212 | ||||||
Actual Study Completion Date | December 2010 | ||||||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Norway | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00594269 | ||||||
Other Study ID Numbers ICMJE | F06001 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust | ||||||
Study Sponsor ICMJE | Sykehuset Innlandet HF | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Sykehuset Innlandet HF | ||||||
Verification Date | February 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |