Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

This study has been completed.
Sponsor:
Collaborator:
Demensforbundet, Norway
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00433121
First received: February 1, 2007
Last updated: August 23, 2007
Last verified: August 2007
  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: Olanzapine
Drug: Haloperidole
Drug: Quetiapin
Drug: Escitalopram
Drug: Citalopram
Drug: Sertralin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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.

  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: NCT00433121

Locations
Norway
Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, Norway, 2312
Sponsors and Collaborators
Sykehuset Innlandet HF
Demensforbundet, Norway
Investigators
Study Chair: Knut Engedal, Ph D The Norwegian Centre for Dementia Research (NCDR), Norway
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00433121     History of Changes
Other Study ID Numbers: 101
Study First Received: February 1, 2007
Last Updated: August 23, 2007
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:
Antidepressive Agents
Neuroleptica
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
Olanzapine
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
Cholinergic Antagonists

ClinicalTrials.gov processed this record on August 21, 2014