Dementia Antipsychotics And Antidepressants Discontinuation Study (DESEP)
This study has been completed.
Sponsor:
Sykehuset Innlandet HF
Collaborators:
Ullevaal University Hospital
Eikertun Nursing Home
University of Bergen
Innlandet Hospital Trust, Sanderud
Innlandet Hospital Trust, Reinsvoll
Diakonhjemmet Hospital
Sykehuset Telemark
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
First received: January 3, 2008
Last updated: February 22, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT. |
Resource links provided by NLM:
Drug Information available for:
Citalopram hydrobromide
Citalopram
Paroxetine
Paroxetine hydrochloride
Sertraline hydrochloride
Sertraline
Risperidone
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by Sykehuset Innlandet HF:
Primary Outcome Measures:
- Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in UPDRS subscale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in Severe Impairment Battery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in Lawton's PADL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Oxazepam given p.n. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Number of falls [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Quality of Life - Alzheimer disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Clinical Dementia Rating [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 149 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
Discontinuation of antipsychotic or antidepressants
|
Drug: Risperidone
Discontinuation
Other Name: ATC code N05AX 08
Drug: Escitalopram
Discontinuation
Other Name: ATC code N06AB 10
Drug: Citalopram
Discontinuation
Other Name: ATC code N06AB 04
Drug: Sertraline
Discontinuation
Other Name: ATC code N06AB 06
Drug: Paroxetine
Discontinuation
Other Name: ATC code N06AB 05
|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594269
Locations
| Norway | |
| Sykehuset Innlandet HF - Sanderud | |
| Ottestad, Oppland, Norway, 2312 | |
| Sykehuset Innlandet HF | |
| Reinsvoll, Oppland, Norway, 2840 | |
| University of Bergen, Løvaasen Nursing Home | |
| Bergen, Norway | |
| Eikertun Nursing Home | |
| Hokksund, Norway | |
| The Nordmøre and Romsdal Hospital Trust | |
| Molde, Norway | |
| Diakonihjemmets Hospital | |
| Oslo, Norway | |
| Ullevaal University Hospital | |
| Oslo, Norway | |
| Telemark Hospital | |
| Skien, Norway | |
Sponsors and Collaborators
Sykehuset Innlandet HF
Ullevaal University Hospital
Eikertun Nursing Home
University of Bergen
Innlandet Hospital Trust, Sanderud
Innlandet Hospital Trust, Reinsvoll
Diakonhjemmet Hospital
Sykehuset Telemark
The Nordmøre and Romsdal Hospital Trust
Songdalstunet Nursing Home
Sykehuset Buskerud HF
Kroken Nursing Home, Tromsø
Kløveråsen, Bodø
Bjørgene Omsorgssenter, Haugesund
Alesund Hospital
Investigators
| 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
No publications provided by Sykehuset Innlandet HF
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sverre Bergh, Cand Med, Researcher., Innlandet Hospital Trust |
| ClinicalTrials.gov Identifier: | NCT00594269 History of Changes |
| Other Study ID Numbers: | F06001 |
| Study First Received: | January 3, 2008 |
| Last Updated: | February 22, 2011 |
| 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:
|
Antidepressants Antipsychotics 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 Paroxetine Sertraline Dexetimide Risperidone Antipsychotic Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013