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Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

This study has been completed.
Demensforbundet, Norway
Information provided by:
Sykehuset Innlandet HF Identifier:
First received: February 1, 2007
Last updated: August 23, 2007
Last verified: August 2007
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
Drug: Risperidone
Drug: Olanzapine
Drug: Haloperidole
Drug: Quetiapin
Drug: Escitalopram
Drug: Citalopram
Drug: Sertralin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.

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 ]
  • Changes in weight [ Time Frame: 24 weeks ]
  • Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
  • Changes in UPDRS subscale [ Time Frame: 24 weeks ]
  • Changes in "Quality of Live - Alzheimer Disease" [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]
  • Changes in Lawton's PADL [ Time Frame: 24 weeks ]
  • Oxazepam given p.n. [ Time Frame: 24 weeks ]
  • Drop outs [ Time Frame: 24 weeks ]

Enrollment: 24
Study Start Date: September 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: A
Discontinuation of neuroleptic or anti depressants
Drug: Risperidone Drug: Olanzapine Drug: Haloperidole Drug: Quetiapin Drug: Escitalopram Drug: Citalopram Drug: Sertralin

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 in use, despite its lack of clinical evidence.

We will discontinue antipsychotics in one group of 12 patients and antidepressants in one group of 12 patients. 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 an open labelled study with no control group. Based on the results of this study, we will design a RCT study with placebo-controlled group.


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
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Please refer to this study by its identifier: NCT00433121

Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, Norway, 2312
Sponsors and Collaborators
Sykehuset Innlandet HF
Demensforbundet, Norway
Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway
  More Information Identifier: NCT00433121     History of Changes
Other Study ID Numbers: 101
Study First Received: February 1, 2007
Last Updated: August 23, 2007

Keywords provided by Sykehuset Innlandet HF:
Antidepressive Agents
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
Antidepressive Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Tranquilizing Agents
Central Nervous System Depressants
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017