Treating Behavioral Disturbances in Individuals With Dementia
NCT ID: NCT00073658
Last Updated: 2014-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2000-01-31
2005-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Citalopram
Risperidone
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Bruce G. Pollock, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
Maxwell 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.
Carnahan 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.
Mamo 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.
Kastango 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.
Bies 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.
Mulsant 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.
Bharucha 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.
Lotrich 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.
Culo 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.
Other Identifiers
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