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Treating Behavioral Disturbances in Individuals With Dementia
This study has been completed.
First Received: December 2, 2003   Last Updated: February 18, 2008   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00073658
  Purpose

This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).


Condition Intervention Phase
Dementia
Drug: Citalopram
Drug: Risperidone
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Continuation Pharmacotherapy for Agitation of Dementia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 137
Study Start Date: January 2000
Study Completion Date: June 2005
Estimated Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073658

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: Bruce G. Pollock, MD, PhD University of Pittsburgh
  More Information

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.
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.
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. Review.
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.
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.
Bharucha AJ, Rosen J, Mulsant BH, Pollock BG. Assessment of behavioral and psychological symptoms of dementia. CNS Spectr. 2000 Nov;7(11):797-802.
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.

Study ID Numbers: R01 MH59666-02, DSIR GT-GP
Study First Received: December 2, 2003
Last Updated: February 18, 2008
ClinicalTrials.gov Identifier: NCT00073658     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
Alzheimer disease
Aggression
Delusions
Paranoid behavior

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Dementia
Antidepressive Agents
Tranquilizing Agents
Nervous System Diseases
Risperidone
Central Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Serotonin Agents
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009