Dementia Antipsychotics And Antidepressants Discontinuation Study

Condition(s) targeted: Dementia

Intervention: Risperidone (Drug); Escitalopram (Drug); Citalopram (Drug); Sertraline (Drug); Paroxetine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sykehuset Innlandet HF

Official(s) and/or principal investigator(s):
Knut Engedal, Ph D, Study Chair, Affiliation: The Norwegian Centre for Dementia Research (NCDR), Norway
Sverre Bergh, MD, Principal Investigator, Affiliation: Innlandet Hospital Trust, Sanderud

Overall contact:
Sverre Bergh, MB, Phone: +47 45 67 93 93, Email: sverre.bergh@sykehuset.innlandet.no

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Changes in Neuropsychiatric Inventory

Changes in Cornell's Depression Scale

Changes in UPDRS subscale

Secondary outcome:

Changes in Severe Impairment Battery

Changes in Lawton's PADL

Oxazepam given p.n.

Number of falls

Changes in Body Weight

Quality of Life - Alzheimer disease

Clinical Dementia Rating

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Sverre Bergh, MB, Phone: +47 45 67 93 93, Email: sverre.bergh@sykehuset.innlandet.no

Ullevaal University Hospital, Oslo, Norway; Recruiting
Inger M Tjaernaas, MD
Inger M Tjaernaas, MD, Principal Investigator

Diakonihjemmets Hospital, Oslo, Norway; Recruiting
Albert Bolsatd, MD
Albert Bolstad, MD, Principal Investigator

Eikertun Nursing Home, Hokksund, Norway; Recruiting
Olav Aga, MD
Olav Aga, MD, Principal Investigator

Telemark Hospital, Skien, Norway; Recruiting
Marianne Holm, MD
Marianne Holm, MD, Principal Investigator

University of Bergen, Løvaasen Nursing Home, Bergen, Norway; Recruiting
Kristian Jansen, MD
Kristian Jansen, MD, Principal Investigator
Jo K Herfjord, MD, Sub-Investigator
Dagrun Gunnarson, MD, Sub-Investigator

The Nordmøre and Romsdal Hospital Trust, Molde, Norway; Recruiting
Inge Rypdal, MD
Inge Rypdal, MD, Principal Investigator

Sykehuset Innlandet HF - Sanderud, Ottestad, Oppland 2312, Norway; Recruiting
Sverre Bergh, MB, Phone: +47 45679393, Email: sverre.bergh@sykehuset.innlandet.no
Tom Borza, MD, Sub-Investigator
Ola Bækkedal, MD, Sub-Investigator

Sykehuset Innlandet HF, Reinsvoll, Oppland 2840, Norway; Recruiting
Racih Ayati, MD
Rachid Ayati, MD, Principal Investigator

Starting date: August 2008
Ending date: March 2010
Last updated: September 12, 2008