NCT00594269

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

2.3 years

First QC Date

January 3, 2008

Last Update Submit

February 22, 2011

Conditions

Dementia

Keywords

AntidepressantsAntipsychoticsDementiaDiscontinuation studyBehavioural- and Psychological Symptoms in Dementia

Outcome Measures

Primary Outcomes (3)

  • Changes in Neuropsychiatric Inventory

    24 weeks

  • Changes in Cornell's Depression Scale

    24 weeks

  • Changes in UPDRS subscale

    24 weeks

Secondary Outcomes (7)

  • Changes in Severe Impairment Battery

    24 weeks

  • Changes in Lawton's PADL

    24 weeks

  • Oxazepam given p.n.

    24 weeks

  • Number of falls

    24 weeks

  • Changes in Body Weight

    24 weeks

  • +2 more secondary outcomes

Study Arms (1)

A

PLACEBO COMPARATOR

Discontinuation of antipsychotic or antidepressants

Drug: RisperidoneDrug: EscitalopramDrug: CitalopramDrug: SertralineDrug: Paroxetine

Interventions

RisperidoneDRUG

Discontinuation

Also known as: ATC code N05AX 08
A
EscitalopramDRUG

Discontinuation

Also known as: ATC code N06AB 10
A
CitalopramDRUG

Discontinuation

Also known as: ATC code N06AB 04
A
SertralineDRUG

Discontinuation

Also known as: ATC code N06AB 06
A
ParoxetineDRUG

Discontinuation

Also known as: ATC code N06AB 05
A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia of other origin
  • Psychiatric disease
  • Life expectancy less than 3 months
  • Acute infection last 10 days
  • Unstable Diabetes Mellitus
  • Terminal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sykehuset Innlandet HF - Sanderud

Ottestad, Oppland, 2312, Norway

Location

Sykehuset Innlandet HF

Reinsvoll, Oppland, 2840, Norway

Location

University of Bergen, Løvaasen Nursing Home

Bergen, Norway

Location

Eikertun Nursing Home

Hokksund, Norway

Location

The Nordmøre and Romsdal Hospital Trust

Molde, Norway

Location

Diakonihjemmets Hospital

Oslo, Norway

Location

Ullevaal University Hospital

Oslo, Norway

Location

Telemark Hospital

Skien, Norway

Location

Related Publications (1)

  • 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.

    PMID: 22408266DERIVED

MeSH Terms

Conditions

Dementia

Interventions

RisperidoneEscitalopramCitalopramSertralineParoxetine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPiperidines

Study Officials

  • Knut Engedal, Ph D

    The Norwegian Centre for Dementia Research (NCDR), Norway

    STUDY CHAIR

  • Sverre Bergh, MD

    Innlandet Hospital Trust, Sanderud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

NO(8)