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| Name | Class |
|---|---|
| Demensforbundet, Norway | UNKNOWN |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Discontinuation of neuroleptic or anti depressants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug |
| ||
| Olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neuropsychiatric Inventory | 24 weeks | |
| Changes in weight | 24 weeks | |
| Changes in Cornell's Depression Scale | 24 weeks | |
| Changes in UPDRS subscale | 24 weeks | |
| Changes in "Quality of Live - Alzheimer Disease" | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Severe Impairment Battery | 24 weeks | |
| Changes in Lawton's PADL | 24 weeks | |
| Oxazepam given p.n. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Engedal, Ph D | The Norwegian Centre for Dementia Research (NCDR), Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sykehuset Innlandet HF - Sanderud | Ottestad | Oppland | 2312 | Norway |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| D000089983 | Escitalopram |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Haloperidole | Drug |
|
| Quetiapin | Drug |
|
| Escitalopram | Drug |
|
| Citalopram | Drug |
|
| Sertralin | Drug |
|
| 24 weeks |
| Drop outs | 24 weeks |
| D001523 | Mental Disorders |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |