AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2003 (estimated)
  2. Study startJan 2000
  3. Primary completionJun 2005
  4. Study completionJun 2005

Resources

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
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 12003247

  • 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.

    PubMed 12083597

  • 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.

    PubMed 12397838

  • 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.

    PubMed 11870012

  • 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.

    PubMed 12427579

  • 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.

    PubMed 12427578

  • 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.

    PubMed 12578438

  • 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.

    PubMed 12947242

  • 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.

    PubMed 12749731

  • 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.

    PubMed 20625270

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in