NCT00433121

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
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 24, 2007

Status Verified

August 1, 2007

First QC Date

February 1, 2007

Last Update Submit

August 23, 2007

Conditions

Dementia

Keywords

Antidepressive AgentsNeurolepticaDementiaDiscontinuation studyBehavioural- and Psychological Symptoms in Dementia

Outcome Measures

Primary Outcomes (5)

  • Changes in Neuropsychiatric Inventory

    24 weeks

  • Changes in weight

    24 weeks

  • Changes in Cornell's Depression Scale

    24 weeks

  • Changes in UPDRS subscale

    24 weeks

  • Changes in "Quality of Live - Alzheimer Disease"

    24 weeks

Secondary Outcomes (4)

  • Changes in Severe Impairment Battery

    24 weeks

  • Changes in Lawton's PADL

    24 weeks

  • Oxazepam given p.n.

    24 weeks

  • Drop outs

    24 weeks

Study Arms (1)

A

EXPERIMENTAL

Discontinuation of neuroleptic or anti depressants

Drug: RisperidoneDrug: OlanzapineDrug: HaloperidoleDrug: QuetiapinDrug: EscitalopramDrug: CitalopramDrug: Sertralin

Interventions

RisperidoneDRUG
A
OlanzapineDRUG
A
HaloperidoleDRUG
A
QuetiapinDRUG
A
EscitalopramDRUG
A
CitalopramDRUG
A
SertralinDRUG
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 (1)

Sykehuset Innlandet HF - Sanderud

Ottestad, Oppland, 2312, Norway

Location

MeSH Terms

Conditions

Dementia

Interventions

RisperidoneOlanzapineEscitalopramCitalopram

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropylaminesAminesOrganic ChemicalsNitrilesBenzofurans

Study Officials

  • Knut Engedal, Ph D

    The Norwegian Centre for Dementia Research (NCDR), Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 9, 2007

Study Start

September 1, 2006

Study Completion

August 1, 2007

Last Updated

August 24, 2007

Record last verified: 2007-08

Locations

NO(1)