Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ullevaal University Hospital | OTHER |
| Eikertun Nursing Home | OTHER |
| University of Bergen | OTHER |
| Innlandet Hospital Trust, Sanderud |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Discontinuation of antipsychotic or antidepressants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | Discontinuation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neuropsychiatric Inventory | 24 weeks | |
| Changes in Cornell's Depression Scale | 24 weeks | |
| Changes in UPDRS subscale | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Severe Impairment Battery | 24 weeks | |
| Changes in Lawton's PADL | 24 weeks | |
| Oxazepam given p.n. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Knut Engedal, Ph D | The Norwegian Centre for Dementia Research (NCDR), Norway | Study Chair |
| Sverre Bergh, MD | Innlandet Hospital Trust, Sanderud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sykehuset Innlandet HF - Sanderud | Ottestad | Oppland | 2312 | Norway | ||
| Sykehuset Innlandet HF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22408266 | Derived | Bergh S, Selbaek G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012 Mar 9;344:e1566. doi: 10.1136/bmj.e1566. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| D000089983 | Escitalopram |
| D015283 | Citalopram |
| D020280 | Sertraline |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| UNKNOWN |
| Innlandet Hospital Trust, Reinsvoll | UNKNOWN |
| Diakonhjemmet Hospital | OTHER |
| Sykehuset Telemark | OTHER_GOV |
| The Nordmøre and Romsdal Hospital Trust | UNKNOWN |
| Songdalstunet Nursing Home | OTHER |
| Sykehuset Buskerud HF | OTHER |
| Kroken Nursing Home, Tromsø | OTHER |
| Kløveråsen, Bodø | UNKNOWN |
| Bjørgene Omsorgssenter, Haugesund | UNKNOWN |
| Alesund Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| Escitalopram | Drug | Discontinuation |
|
|
| Citalopram | Drug | Discontinuation |
|
|
| Sertraline | Drug | Discontinuation |
|
|
| Paroxetine | Drug | Discontinuation |
|
|
| 24 weeks |
| Number of falls | 24 weeks |
| Changes in Body Weight | 24 weeks |
| Quality of Life - Alzheimer disease | 24 weeks |
| Clinical Dementia Rating | 24 weeks |
| Reinsvoll |
| Oppland |
| 2840 |
| Norway |
| 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 |
| D001523 | Mental Disorders |
| D011437 |
| Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |