DementiaPhase 2NCT00073658
Treating Behavioral Disturbances in Individuals With Dementia
A Phase 2 study testing Citalopram and Risperidone in people with Dementia, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Citalopram and Risperidone
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jun 2005
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease
- Inpatient admittance to Western Psychiatric Institute and Clinic
- Written informed consent from participant's legally authorized representative with the participant's assent
- Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety
- Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items
- Ability to participate in study evaluation and ingest oral medication
Who cannot join
- Diagnosis of an unstable medical illness within the last 12 months
- Kidney or liver dysfunction
- Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia
- Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS
- Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function
- History of schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, or bipolar affective disorder
Show all 10Show fewer
- Alcohol or substance abuse or dependence
- Receiving monoamine oxidase inhibitors within 15 days of study
- Display behaviors which could endanger the participant's life or the lives of others
- Received fluoxetine within 4 weeks of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Continuation Pharmacotherapy for Agitation of Dementia
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).
Read the detailed description
Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these disturbances. This study will use citalopram and risperidone to treat people with dementia-related behavior problems.
Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start. Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks. Limited doses of the sedative lorazepam may be administered as needed throughout the study. During the first 2 weeks of the study, participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized. Following hospital discharge, participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks. Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter. Experimental laboratory measures will be collected at study start, Week 1, Week 2, and every 2 weeks thereafter until Week 12. Upon study completion, patients may continue to receive citalopram or risperidone under the supervision of their current physicians. Three months after study completion, participants may be contacted for a follow-up report of their psychiatric and medical status.
- Conditions
- Dementia
- Being tested
- Citalopram, Risperidone
- Keywords
- Alzheimer disease, Aggression, Delusions, Paranoid behavior
- Medical subject headings
- Dementia, Alzheimer Disease, Aggression, Delusions, Paranoid Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
RisperidoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2003 (estimated)
- Study startJan 2000
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 137 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bruce G. Pollock, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073658
- Sponsor's protocol ID
- R01MH059666-02
- Other IDs
- R01MH059666-02, DSIR GT-GP
- Status last verified
- Mar 2014
- First submitted
- 2 Dec 2003
- Last updated
- 10 Mar 2014
- Results posted
- No
Publications
Sweet RA, Pollock BG, Sukonick DL, Mulsant BH, Rosen J, Klunk WE, Kastango KB, DeKosky ST, Ferrell RE. The 5-HTTPR polymorphism confers liability to a combined phenotype of psychotic and aggressive behavior in Alzheimer disease. Int Psychogeriatr. 2001 Dec;13(4):401-9. doi: 10.1017/s1041610201007827.
PubMed 12003247Maxwell RA, Sweet RA, Mulsant BH, Rosen J, Kirshner MA, Kastango KB, Pollock BG. Risperidone and 9-hydroxyrisperidone concentrations are not dependent on age or creatinine clearance among elderly subjects. J Geriatr Psychiatry Neurol. 2002 Summer;15(2):77-81. doi: 10.1177/089198870201500205.
PubMed 12083597Carnahan RM, Lund BC, Perry PJ, Pollock BG. A critical appraisal of the utility of the serum anticholinergic activity assay in research and clinical practice. Psychopharmacol Bull. 2002 Spring;36(2):24-39.
PubMed 12397838Mamo DC, Sweet RA, Mulsant BH, Rosen J, Pollock BG: Neuroleptic-induced Parkinsonism in Alzheimer's disease. Psychiatric Annals 32:249-252, 2002.
Pollock BG, Mulsant BH, Rosen J, Sweet RA, Mazumdar S, Bharucha A, Marin R, Jacob NJ, Huber KA, Kastango KB, Chew ML. Comparison of citalopram, perphenazine, and placebo for the acute treatment of psychosis and behavioral disturbances in hospitalized, demented patients. Am J Psychiatry. 2002 Mar;159(3):460-5. doi: 10.1176/appi.ajp.159.3.460.
PubMed 11870012Kastango KB, Kim Y, Dew MA, Mazumdar S, Mulsant BH, Rosen J, Reynolds III CF, Pilkonis PA, Pollock BG. Verification of scale sub-domains in elderly patients with dementia: a confirmatory factor-analytic approach. Am J Geriatr Psychiatry. 2002 Nov-Dec;10(6):706-14.
PubMed 12427579Bies RR, Gastonguay MR, Coley KC, Kroboth PD, Pollock BG. Evaluating the consistency of pharmacotherapy exposure by use of state-of-the-art techniques. Am J Geriatr Psychiatry. 2002 Nov-Dec;10(6):696-705.
PubMed 12427578Mulsant BH, Pollock BG, Kirshner M, Shen C, Dodge H, Ganguli M. Serum anticholinergic activity in a community-based sample of older adults: relationship with cognitive performance. Arch Gen Psychiatry. 2003 Feb;60(2):198-203. doi: 10.1001/archpsyc.60.2.198.
PubMed 12578438Bharucha AJ, Rosen J, Mulsant BH, Pollock BG. Assessment of behavioral and psychological symptoms of dementia. CNS Spectr. 2002 Nov;7(11):797-802. doi: 10.1017/s1092852900024317.
PubMed 12947242Lotrich FE, Pollock BG, Ferrell RE. Serotonin transporter promoter polymorphism in African Americans : allele frequencies and implications for treatment. Am J Pharmacogenomics. 2003;3(2):145-7. doi: 10.2165/00129785-200303020-00007.
PubMed 12749731Culo S, Mulsant BH, Rosen J, Mazumdar S, Blakesley RE, Houck PR, Pollock BG. Treating neuropsychiatric symptoms in dementia with Lewy bodies: a randomized controlled-trial. Alzheimer Dis Assoc Disord. 2010 Oct-Dec;24(4):360-4. doi: 10.1097/WAD.0b013e3181e6a4d7.
PubMed 20625270
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation Pharmacotherapy for Agitation of Dementia
- ClinicalTrials.gov ID
- NCT00073658
- Acronym / sponsor ID
- R01MH059666-02
- Conditions
- Dementia
- Keywords
- Alzheimer disease, Aggression, Delusions, Paranoid behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2000
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 3 Dec 2003 (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.
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).
Detailed description
Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these disturbances. This study will use citalopram and risperidone to treat people with dementia-related behavior problems.
Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start. Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks. Limited doses of the sedative lorazepam may be administered as needed throughout the study. During the first 2 weeks of the study, participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized. Following hospital discharge, participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks. Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter. Experimental laboratory measures will be collected at study start, Week 1, Week 2, and every 2 weeks thereafter until Week 12. Upon study completion, patients may continue to receive citalopram or risperidone under the supervision of their current physicians. Three months after study completion, participants may be contacted for a follow-up report of their psychiatric and medical status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease
- Inpatient admittance to Western Psychiatric Institute and Clinic
- Written informed consent from participant's legally authorized representative with the participant's assent
- Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety
- Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items
Key exclusion criteria (10 listed)
- Diagnosis of an unstable medical illness within the last 12 months
- Kidney or liver dysfunction
- Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia
- Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS
- Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function
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 |
|---|---|---|
| Citalopram | Drug | – |
| Risperidone | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Mar 2014.
- Background: PubMed 12003247Sweet RA, Pollock BG, Sukonick DL, Mulsant BH, Rosen J, Klunk WE, Kastango KB, DeKosky ST, Ferrell RE. The 5-HTTPR polymorphism confers liability to a combined phenotype of psychotic and aggressive behavior in Alzheimer disease. Int Psychogeriatr. 2001 Dec;13(4):401-9. doi: 10.1017/s1041610201007827.
- Background: PubMed 12083597Maxwell RA, Sweet RA, Mulsant BH, Rosen J, Kirshner MA, Kastango KB, Pollock BG. Risperidone and 9-hydroxyrisperidone concentrations are not dependent on age or creatinine clearance among elderly subjects. J Geriatr Psychiatry Neurol. 2002 Summer;15(2):77-81. doi: 10.1177/089198870201500205.
- Background: PubMed 12397838Carnahan RM, Lund BC, Perry PJ, Pollock BG. A critical appraisal of the utility of the serum anticholinergic activity assay in research and clinical practice. Psychopharmacol Bull. 2002 Spring;36(2):24-39.
- BackgroundMamo DC, Sweet RA, Mulsant BH, Rosen J, Pollock BG: Neuroleptic-induced Parkinsonism in Alzheimer's disease. Psychiatric Annals 32:249-252, 2002.
- Background: PubMed 11870012Pollock BG, Mulsant BH, Rosen J, Sweet RA, Mazumdar S, Bharucha A, Marin R, Jacob NJ, Huber KA, Kastango KB, Chew ML. Comparison of citalopram, perphenazine, and placebo for the acute treatment of psychosis and behavioral disturbances in hospitalized, demented patients. Am J Psychiatry. 2002 Mar;159(3):460-5. doi: 10.1176/appi.ajp.159.3.460.
- Background: PubMed 12427579Kastango KB, Kim Y, Dew MA, Mazumdar S, Mulsant BH, Rosen J, Reynolds III CF, Pilkonis PA, Pollock BG. Verification of scale sub-domains in elderly patients with dementia: a confirmatory factor-analytic approach. Am J Geriatr Psychiatry. 2002 Nov-Dec;10(6):706-14.
- Background: PubMed 12427578Bies RR, Gastonguay MR, Coley KC, Kroboth PD, Pollock BG. Evaluating the consistency of pharmacotherapy exposure by use of state-of-the-art techniques. Am J Geriatr Psychiatry. 2002 Nov-Dec;10(6):696-705.
- Background: PubMed 12578438Mulsant BH, Pollock BG, Kirshner M, Shen C, Dodge H, Ganguli M. Serum anticholinergic activity in a community-based sample of older adults: relationship with cognitive performance. Arch Gen Psychiatry. 2003 Feb;60(2):198-203. doi: 10.1001/archpsyc.60.2.198.
- Background: PubMed 12947242Bharucha AJ, Rosen J, Mulsant BH, Pollock BG. Assessment of behavioral and psychological symptoms of dementia. CNS Spectr. 2002 Nov;7(11):797-802. doi: 10.1017/s1092852900024317.
- Background: PubMed 12749731Lotrich FE, Pollock BG, Ferrell RE. Serotonin transporter promoter polymorphism in African Americans : allele frequencies and implications for treatment. Am J Pharmacogenomics. 2003;3(2):145-7. doi: 10.2165/00129785-200303020-00007.
- Derived from this study: PubMed 20625270Culo S, Mulsant BH, Rosen J, Mazumdar S, Blakesley RE, Houck PR, Pollock BG. Treating neuropsychiatric symptoms in dementia with Lewy bodies: a randomized controlled-trial. Alzheimer Dis Assoc Disord. 2010 Oct-Dec;24(4):360-4. doi: 10.1097/WAD.0b013e3181e6a4d7.
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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.
Bruce G. Pollock, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram and Risperidone in people with Dementia, run by University of Pittsburgh at 1 site in United States.
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 6 inclusion and 10 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 10 Mar 2014. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073658, which also lists 11 linked publications.
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 10 Mar 2014.