DementiaPhase 4NCT00433121
Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD
A Phase 4 study testing Risperidone, Olanzapine and Haloperidole in people with Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Risperidone, Olanzapine and Haloperidole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia of other origin
- Psychiatric disease
- Life expectancy less than 3 months
- Acute infection last 10 days
- Unstable Diabetes Mellitus
- Terminal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).
Read the 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 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.
- Conditions
- Dementia
- Being tested
- Risperidone, Olanzapine, Haloperidole, Quetiapin, Escitalopram
- Keywords
- Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
OlanzapineDrug
HaloperidoleDrug
QuetiapinDrug
EscitalopramDrug
CitalopramDrug
SertralinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Discontinuation of neuroleptic or anti depressants Receives: Drug: Risperidone; Drug: Olanzapine; Drug: Haloperidole; Drug: Quetiapin; Drug: Escitalopram; Drug: Citalopram; Drug: Sertralin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neuropsychiatric Inventory
Measured: 24 weeks
Changes in weight
Measured: 24 weeks
Changes in Cornell's Depression Scale
Measured: 24 weeks
Changes in UPDRS subscale
Measured: 24 weeks
Changes in "Quality of Live - Alzheimer Disease"
Measured: 24 weeks
Secondary outcomes (4)
Changes in Severe Impairment Battery
Measured: 24 weeks
Changes in Lawton's PADL
Measured: 24 weeks
Oxazepam given p.n.
Measured: 24 weeks
Drop outs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
- Study startSep 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Demensforbundet, Norway
- Investigators
- Knut Engedal, Ph D, Study chair, The Norwegian Centre for Dementia Research (NCDR), Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433121
- Sponsor's protocol ID
- 101
- Status last verified
- Aug 2007
- First submitted
- 1 Feb 2007
- Last updated
- 24 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study.
- ClinicalTrials.gov ID
- NCT00433121
- Acronym / sponsor ID
- 101
- Conditions
- Dementia
- Keywords
- Antidepressive Agents, Neuroleptica, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Demensforbundet, Norway
- Study start
- Sep 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 9 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Risperidone, Drug: Olanzapine, Drug: Haloperidole, Drug: Quetiapin, Drug: Escitalopram, Drug: Citalopram, Drug: SertralinDiscontinuation of neuroleptic or anti depressants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Dementia of other origin
- Psychiatric disease
- Life expectancy less than 3 months
- Acute infection last 10 days
- Unstable Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone | Drug | A |
| Olanzapine | Drug | A |
| Haloperidole | Drug | A |
| Quetiapin | Drug | A |
| Escitalopram | Drug | A |
| Citalopram | Drug | A |
| Sertralin | Drug | A |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Engedal, Ph D study chair
The Norwegian Centre for Dementia Research (NCDR), Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone, Olanzapine and Haloperidole in people with Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neuropsychiatric Inventory (time frame: 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2007.