DementiaPhase 4DESEPNCT00594269
Dementia Antipsychotics And Antidepressants Discontinuation Study
A Phase 4 study testing Risperidone, Escitalopram and Citalopram in people with Dementia, run by Sykehuset Innlandet HF at 8 sites 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, Escitalopram and Citalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 8 sitesNorway
- Study dates
- Aug 2008to Dec 2010
- 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
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
University of Bergen, Løvaasen Nursing Home
Bergen
Eikertun Nursing Home
Hokksund
The Nordmøre and Romsdal Hospital Trust
Molde
Diakonihjemmets Hospital
Oslo
Ullevaal University Hospital
Oslo
Sykehuset Innlandet HF - Sanderud
Ottestad, Oppland, 2312
Sykehuset Innlandet HF
Reinsvoll, Oppland, 2840
Telemark Hospital
Skien
About this study
Official title: Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
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 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.
- Conditions
- Dementia
- Being tested
- Risperidone, Escitalopram, Citalopram, Sertraline, Paroxetine
- Keywords
- Antidepressants, Antipsychotics, 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
Also called ATC code N05AX 08
Discontinuation
EscitalopramDrug
Also called ATC code N06AB 10
Discontinuation
CitalopramDrug
Also called ATC code N06AB 04
Discontinuation
SertralineDrug
Also called ATC code N06AB 06
Discontinuation
ParoxetineDrug
Also called ATC code N06AB 05
Discontinuation
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Discontinuation of antipsychotic or antidepressants Receives: Drug: Risperidone; Drug: Escitalopram; Drug: Citalopram; Drug: Sertraline; Drug: Paroxetine |
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 Cornell's Depression Scale
Measured: 24 weeks
Changes in UPDRS subscale
Measured: 24 weeks
Secondary outcomes (7)
Changes in Severe Impairment Battery
Measured: 24 weeks
Changes in Lawton's PADL
Measured: 24 weeks
Oxazepam given p.n.
Measured: 24 weeks
Number of falls
Measured: 24 weeks
Changes in Body Weight
Measured: 24 weeks
Quality of Life - Alzheimer disease
Measured: 24 weeks
Clinical Dementia Rating
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 posted15 Jan 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Knut Engedal, Ph D, Study chair, The Norwegian Centre for Dementia Research (NCDR), NorwaySverre Bergh, MD, Principal investigator, Innlandet Hospital Trust, Sanderud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594269
- Sponsor's protocol ID
- F06001
- Acronym
- DESEP
- Status last verified
- Feb 2011
- First submitted
- 3 Jan 2008
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22408266
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. 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 - a 24 Weeks Double Blind RCT.
- ClinicalTrials.gov ID
- NCT00594269
- Acronym / sponsor ID
- DESEP / F06001
- Conditions
- Dementia
- Keywords
- Antidepressants, Antipsychotics, Dementia, Discontinuation study, Behavioural- and Psychological Symptoms in Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- 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
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jan 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Risperidone, Drug: Escitalopram, Drug: Citalopram, Drug: Sertraline, Drug: ParoxetineDiscontinuation of antipsychotic or antidepressants |
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 |
|---|---|---|
| RisperidoneAlso: ATC code N05AX 08Discontinuation | Drug | A |
| EscitalopramAlso: ATC code N06AB 10Discontinuation | Drug | A |
| CitalopramAlso: ATC code N06AB 04Discontinuation | Drug | A |
| SertralineAlso: ATC code N06AB 06Discontinuation | Drug | A |
| ParoxetineAlso: ATC code N06AB 05Discontinuation | Drug | A |
Primary outcome
Changes in Neuropsychiatric Inventory
Time frame: 24 weeks
Changes in Cornell's Depression Scale
Time frame: 24 weeks
Changes in UPDRS subscale
Time frame: 24 weeks
7 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
Number of falls
Time frame: 24 weeks
Changes in Body Weight
Time frame: 24 weeks
Quality of Life - Alzheimer disease
Time frame: 24 weeks
Clinical Dementia Rating
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 23 Feb 2011.
- Derived from this study: PubMed 22408266Bergh 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.
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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
Sverre Bergh, MD principal investigator
Innlandet Hospital Trust, Sanderud
8 sites 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, Escitalopram and Citalopram in people with Dementia, run by Sykehuset Innlandet HF at 8 sites 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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594269, which also lists 1 linked publication.
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 23 Feb 2011.