Dementia Antipsychotics And Antidepressants Discontinuation Study

NCT ID: NCT00594269

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Discontinuation of antipsychotic or antidepressants

Group Type PLACEBO_COMPARATOR

Risperidone

Intervention Type DRUG

Discontinuation

Escitalopram

Intervention Type DRUG

Discontinuation

Citalopram

Intervention Type DRUG

Discontinuation

Sertraline

Intervention Type DRUG

Discontinuation

Paroxetine

Intervention Type DRUG

Discontinuation

Interventions

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Risperidone

Discontinuation

Intervention Type DRUG

Escitalopram

Discontinuation

Intervention Type DRUG

Citalopram

Discontinuation

Intervention Type DRUG

Sertraline

Discontinuation

Intervention Type DRUG

Paroxetine

Discontinuation

Intervention Type DRUG

Other Intervention Names

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ATC code N05AX 08 ATC code N06AB 10 ATC code N06AB 04 ATC code N06AB 06 ATC code N06AB 05

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Eikertun Nursing Home

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Innlandet Hospital Trust, Sanderud

UNKNOWN

Sponsor Role collaborator

Innlandet Hospital Trust, Reinsvoll

UNKNOWN

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role collaborator

The Nordmøre and Romsdal Hospital Trust

UNKNOWN

Sponsor Role collaborator

Songdalstunet Nursing Home

OTHER

Sponsor Role collaborator

Sykehuset Buskerud HF

OTHER

Sponsor Role collaborator

Kroken Nursing Home, Tromsø

OTHER

Sponsor Role collaborator

Kløveråsen, Bodø

UNKNOWN

Sponsor Role collaborator

Bjørgene Omsorgssenter, Haugesund

UNKNOWN

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role lead

Responsible Party

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Innlandet Hospital Trust

Principal Investigators

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Knut Engedal, Ph D

Role: STUDY_CHAIR

The Norwegian Centre for Dementia Research (NCDR), Norway

Sverre Bergh, MD

Role: PRINCIPAL_INVESTIGATOR

Innlandet Hospital Trust, Sanderud

Locations

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Sykehuset Innlandet HF - Sanderud

Ottestad, Oppland, Norway

Site Status

Sykehuset Innlandet HF

Reinsvoll, Oppland, Norway

Site Status

University of Bergen, Løvaasen Nursing Home

Bergen, , Norway

Site Status

Eikertun Nursing Home

Hokksund, , Norway

Site Status

The Nordmøre and Romsdal Hospital Trust

Molde, , Norway

Site Status

Diakonihjemmets Hospital

Oslo, , Norway

Site Status

Ullevaal University Hospital

Oslo, , Norway

Site Status

Telemark Hospital

Skien, , Norway

Site Status

Countries

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Norway

References

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Bergh S, Selbaek 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.

Reference Type DERIVED
PMID: 22408266 (View on PubMed)

Other Identifiers

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F06001

Identifier Type: -

Identifier Source: org_study_id

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