Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
|ClinicalTrials.gov Identifier: NCT00433121|
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : August 24, 2007
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Drug: Risperidone Drug: Olanzapine Drug: Haloperidole Drug: Quetiapin Drug: Escitalopram Drug: Citalopram Drug: Sertralin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||August 2007|
Discontinuation of neuroleptic or anti depressants
- Changes in Neuropsychiatric Inventory [ Time Frame: 24 weeks ]
- Changes in weight [ Time Frame: 24 weeks ]
- Changes in Cornell's Depression Scale [ Time Frame: 24 weeks ]
- Changes in UPDRS subscale [ Time Frame: 24 weeks ]
- Changes in "Quality of Live - Alzheimer Disease" [ Time Frame: 24 weeks ]
- Changes in Severe Impairment Battery [ Time Frame: 24 weeks ]
- Changes in Lawton's PADL [ Time Frame: 24 weeks ]
- Oxazepam given p.n. [ Time Frame: 24 weeks ]
- Drop outs [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433121
|Sykehuset Innlandet HF - Sanderud|
|Ottestad, Oppland, Norway, 2312|
|Study Chair:||Knut Engedal, Ph D||The Norwegian Centre for Dementia Research (NCDR), Norway|