Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

Tracking Information
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; (submitted: January 3, 2008)	Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ]; Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]; Changes in UPDRS subscale [ Time Frame: 24 weeks ]
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; (submitted: January 3, 2008)	Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]; Changes in Lawton's PADL [ Time Frame: 24 weeks ]; Oxazepam given p.n. [ Time Frame: 24 weeks ]; Number of falls [ Time Frame: 24 weeks ]; Changes in Body Weight [ Time Frame: 24 weeks ]; Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ]; Clinical Dementia Rating [ Time Frame: 24 weeks ]
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.
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
Condition ICMJE	Dementia
Intervention ICMJE	Drug: Risperidone Discontinuation Other Name: ATC code N05AX 08; Drug: Escitalopram Discontinuation Other Name: ATC code N06AB 10; Drug: Citalopram Discontinuation Other Name: ATC code N06AB 04; Drug: Sertraline Discontinuation Other Name: ATC code N06AB 06; Drug: Paroxetine Discontinuation Other Name: ATC code N06AB 05
Study Arms	Placebo Comparator: A; Discontinuation of antipsychotic or antidepressants; Interventions: Drug: Risperidone; Drug: Escitalopram; Drug: Citalopram; Drug: Sertraline; Drug: Paroxetine
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 22, 2011)	149
Original Estimated Enrollment ICMJE; (submitted: January 3, 2008)	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: Vascular- or Alzheimer Dementia; Nursing Homes resident for 3 months or more; Given antipsychotics or antidepressants for 3 months or more; Clinical Dementia rating 1, 2 or 3 Exclusion Criteria: Dementia of other origin; Psychiatric disease; Life expectancy less than 3 months; Acute infection last 10 days; Unstable Diabetes Mellitus; Terminal disease
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
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	Ullevaal University Hospital; Eikertun Nursing Home; University of Bergen; Innlandet Hospital Trust, Sanderud; Innlandet Hospital Trust, Reinsvoll; Diakonhjemmet Hospital; Sykehuset Telemark; The Nordmøre and Romsdal Hospital Trust; Songdalstunet Nursing Home; Sykehuset Buskerud HF; Kroken Nursing Home, Tromsø; Kløveråsen, Bodø; Bjørgene Omsorgssenter, Haugesund; Alesund Hospital
Investigators ICMJE	Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway Principal Investigator: Sverre Bergh, MD Innlandet Hospital Trust, Sanderud
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