We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00594269
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : February 23, 2011
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Dementia Drug: Risperidone Drug: Escitalopram Drug: Citalopram Drug: Sertraline Drug: Paroxetine Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : August 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: A
Discontinuation of antipsychotic or antidepressants
Drug: Risperidone
Other Name: ATC code N05AX 08
Drug: Escitalopram
Other Name: ATC code N06AB 10
Drug: Citalopram
Other Name: ATC code N06AB 04
Drug: Sertraline
Other Name: ATC code N06AB 06
Drug: Paroxetine
Other Name: ATC code N06AB 05

Outcome Measures

Primary Outcome Measures :
  1. Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ]
  2. Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
  3. Changes in UPDRS subscale [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]
  2. Changes in Lawton's PADL [ Time Frame: 24 weeks ]
  3. Oxazepam given p.n. [ Time Frame: 24 weeks ]
  4. Number of falls [ Time Frame: 24 weeks ]
  5. Changes in Body Weight [ Time Frame: 24 weeks ]
  6. Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ]
  7. Clinical Dementia Rating [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594269

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
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

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
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Antipsychotic Agents
Antidepressive Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors