Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

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

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Drug: Risperidone; Drug: Escitalopram; Drug: Citalopram; Drug: Sertraline; Drug: Paroxetine

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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • University of Bergen, Løvaasen Nursing Home
  • Hokksund, Norway
    • Eikertun Nursing Home
  • Molde, Norway
    • The Nordmøre and Romsdal Hospital Trust
  • Oslo, Norway
    • Ullevaal University Hospital
  • Oslo, Norway
    • Diakonihjemmets Hospital
  • Skien, Norway
    • Telemark Hospital
  • Oppland
    • Ottestad, Oppland, Norway, 2312
      • Sykehuset Innlandet HF - Sanderud
    • Reinsvoll, Oppland, Norway, 2840
      • Sykehuset Innlandet HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Neuropsychiatric Inventory	24 weeks
Changes in Cornell's Depression Scale	24 weeks
Changes in UPDRS subscale	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Quality of Life - Alzheimer disease	24 weeks
Clinical Dementia Rating	24 weeks

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: Ullevaal University Hospital; University of Bergen; Diakonhjemmet Hospital; Alesund Hospital; Sykehuset Telemark; Sykehuset Buskerud HF; Eikertun Nursing Home; Innlandet Hospital Trust, Sanderud; Innlandet Hospital Trust, Reinsvoll; The Nordmøre and Romsdal Hospital Trust; Songdalstunet Nursing Home; Kroken Nursing Home, Tromsø; Kløveråsen, Bodø; Bjørgene Omsorgssenter, Haugesund
• Investigators: Study Chair: Knut Engedal, Ph D, The Norwegian Centre for Dementia Research (NCDR), Norway; Principal Investigator: Sverre Bergh, MD, Innlandet Hospital Trust, Sanderud

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 3, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Dementia; Antipsychotics; Antidepressants; Discontinuation study; Behavioural- and Psychological Symptoms in Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Sertraline; Citalopram; Paroxetine; Risperidone
• Other Study ID Numbers: F06001