Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00594269
First received: January 3, 2008
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).


Condition Intervention Phase
Dementia
Drug: Risperidone
Drug: Escitalopram
Drug: Citalopram
Drug: Sertraline
Drug: Paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in UPDRS subscale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Severe Impairment Battery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Lawton's PADL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Oxazepam given p.n. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of falls [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Discontinuation of antipsychotic or antidepressants
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594269

Locations
Norway
Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, Norway, 2312
Sykehuset Innlandet HF
Reinsvoll, Oppland, Norway, 2840
University of Bergen, Løvaasen Nursing Home
Bergen, Norway
Eikertun Nursing Home
Hokksund, Norway
The Nordmøre and Romsdal Hospital Trust
Molde, Norway
Diakonihjemmets Hospital
Oslo, Norway
Ullevaal University Hospital
Oslo, Norway
Telemark Hospital
Skien, Norway
Sponsors and Collaborators
Sykehuset Innlandet HF
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
Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway
Principal Investigator: Sverre Bergh, MD Innlandet Hospital Trust, Sanderud
  More Information

No publications provided by Sykehuset Innlandet HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust
ClinicalTrials.gov Identifier: NCT00594269     History of Changes
Other Study ID Numbers: F06001
Study First Received: January 3, 2008
Last Updated: February 22, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sykehuset Innlandet HF:
Antidepressants
Antipsychotics
Dementia
Discontinuation study
Behavioural- and Psychological Symptoms in Dementia

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Paroxetine
Sertraline
Dexetimide
Risperidone
Antipsychotic Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014