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| Sponsor: | Sykehuset Innlandet HF |
|---|---|
| Collaborators: |
Ullevaal University Hospital Eikertun Nursing Home University of Bergen, Løvaasen nursing Home Innlandet Hospital Trust, Sanderud Innlandet Hospital Trust, Reinsvoll Diakonihjemmet Hospital Telemark Hospital The Nordmøre and Romsdal Hospital Trust Songdalstunet Nursing Home Sykehuset Buskerud HF Kroken Nursing Home, Tromsø Kløveråsen, Bodø Bjørgene Omsorgssenter, Haugesund Alesund Hospital |
| Information provided by: | Sykehuset Innlandet HF |
| ClinicalTrials.gov Identifier: | NCT00594269 |
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: Escitalopram Drug: Citalopram Drug: Sertraline Drug: Paroxetine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT. |
| Estimated Enrollment: | 212 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
Discontinuation of antipsychotic or antidepressants
|
Drug: Risperidone
Discontinuation
Drug: Escitalopram
Discontinuation
Drug: Citalopram
Discontinuation
Drug: Sertraline
Discontinuation
Drug: Paroxetine
Discontinuation
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sverre Bergh, MB | +47 45 67 93 93 | sverre.bergh@sykehuset-innlandet.no |
| Norway | |
| Ullevaal University Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Inger M Tjaernaas, MD | |
| Principal Investigator: Inger M Tjaernaas, MD | |
| Diakonihjemmets Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Albert Bolsatd, MD | |
| Principal Investigator: Albert Bolstad, MD | |
| Eikertun Nursing Home | Recruiting |
| Hokksund, Norway | |
| Contact: Olav Aga, MD | |
| Principal Investigator: Olav Aga, MD | |
| Telemark Hospital | Recruiting |
| Skien, Norway | |
| Contact: Marianne Holm, MD | |
| Principal Investigator: Marianne Holm, MD | |
| University of Bergen, Løvaasen Nursing Home | Recruiting |
| Bergen, Norway | |
| Contact: Kristian Jansen, MD | |
| Principal Investigator: Kristian Jansen, MD | |
| Sub-Investigator: Jo K Herfjord, MD | |
| Sub-Investigator: Dagrun Gunnarson, MD | |
| The Nordmøre and Romsdal Hospital Trust | Recruiting |
| Molde, Norway | |
| Contact: Inge Rypdal, MD | |
| Principal Investigator: Inge Rypdal, MD | |
| Norway, Oppland | |
| Sykehuset Innlandet HF - Sanderud | Recruiting |
| Ottestad, Oppland, Norway, 2312 | |
| Contact: Sverre Bergh, MB +47 45679393 sverre.bergh@sykehuset-innlandet.no | |
| Sub-Investigator: Tom Borza, MD | |
| Sub-Investigator: Ola Bækkedal, MD | |
| Sykehuset Innlandet HF | Recruiting |
| Reinsvoll, Oppland, Norway, 2840 | |
| Contact: Racih Ayati, MD | |
| Principal Investigator: Rachid Ayati, MD | |
| 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
| Responsible Party: | Innlandet Hospital Trust ( Sverre Bergh, Cand Med, Researcher. ) |
| Study ID Numbers: | F06001 |
| Study First Received: | January 3, 2008 |
| Last Updated: | October 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00594269 History of Changes |
| Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
|
Antidepressants Antipsychotics Dementia Discontinuation study Behavioural- and Psychological Symptoms in Dementia |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Brain Diseases Paroxetine Serotonin Antagonists Mental Disorders Therapeutic Uses Sertraline Dementia Antidepressive Agents, Second-Generation Antidepressive Agents |
Tranquilizing Agents Nervous System Diseases Risperidone Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Serotonin Agents Dopamine Agents Central Nervous System Agents |
