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Dementia Antipsychotics And Antidepressants Discontinuation Study

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00594269
Acronym
DESEP
Enrollment
149
Registered
2008-01-15
Start date
2008-08-31
Completion date
2010-12-31
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Antidepressants, Antipsychotics, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia

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.

Interventions

DRUGRisperidone

Discontinuation

DRUGEscitalopram

Discontinuation

DRUGCitalopram

Discontinuation

DRUGSertraline

Discontinuation

DRUGParoxetine

Discontinuation

Sponsors

Ullevaal University Hospital
CollaboratorOTHER
Eikertun Nursing Home
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Innlandet Hospital Trust, Sanderud
CollaboratorUNKNOWN
Innlandet Hospital Trust, Reinsvoll
CollaboratorUNKNOWN
Diakonhjemmet Hospital
CollaboratorOTHER
Sykehuset Telemark
CollaboratorOTHER_GOV
The Nordmøre and Romsdal Hospital Trust
CollaboratorUNKNOWN
Songdalstunet Nursing Home
CollaboratorOTHER
Sykehuset Buskerud HF
CollaboratorOTHER
Kroken Nursing Home, Tromsø
CollaboratorOTHER
Kløveråsen, Bodø
CollaboratorUNKNOWN
Bjørgene Omsorgssenter, Haugesund
CollaboratorUNKNOWN
Alesund Hospital
CollaboratorOTHER
Sykehuset Innlandet HF
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in Cornell's Depression Scale24 weeks
Changes in UPDRS subscale24 weeks
Changes in Neuropsychiatric Inventory24 weeks

Secondary

MeasureTime frame
Number of falls24 weeks
Changes in Body Weight24 weeks
Changes in Severe Impairment Battery24 weeks
Clinical Dementia Rating24 weeks
Quality of Life - Alzheimer disease24 weeks
Changes in Lawton's PADL24 weeks
Oxazepam given p.n.24 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026