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Serotonergic Pharmacotherapy for Agitation of Dementia (SPAD)

Primary Purpose

Dementia, Alzheimer Disease, Dementia, Vascular

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Citalopram [Celexa]
Perphenazine [Trilafon]
Sponsored by
Bruce Pollock
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Behavioral problems, Agitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets DSM-IV criteria for diagnosis of dementia of the Alzheimer's type (AD), Vascular dementia (VD), mixed (AD and VD) or dementia NOS (Not Otherwise Specified) Presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the Neurobehavioral Rating Scale (NBRS) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization Able to participate in study evaluations and ingest oral medication Has next of kin or a guardian available to consent to patient's participation. Exclusion Criteria: Has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially Parkinson's disease) other than dementia Meets DSM-IV criteria for Delirium upon admission to Western Psychiatric Institute and Clinic Has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol) Is currently being treated with cognitive enhancing drugs (Tacrine or Aricept) or any experimental drug Has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression Has preexisting orthostatic hypotension (with > 20 mmHg change from sitting to standing pressure)

Sites / Locations

  • University of Pittsburgh Western Psychiatric Institute and Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 23, 2001
Last Updated
June 14, 2017
Sponsor
Bruce Pollock
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00009204
Brief Title
Serotonergic Pharmacotherapy for Agitation of Dementia
Acronym
SPAD
Official Title
Serotonergic Pharmacotherapy for Agitation of Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruce Pollock
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
Detailed Description
The principal investigator is conducting an inpatient study at Western Psychiatric Institute and Clinic involving two medications for treatment of emotional and behavioral disturbances that may accompany dementia. In this study, 112 patients will be enrolled for up to 17 days in order to investigate the safety and effectiveness of both medications. Forty-two of these patients will be given a recently FDA-approved antidepressant medication called citalopram and 42 will receive one of our current, usual antipsychotic medications called perphenazine. An additional 28 patients will be given non-active placebo capsules. Which treatment a patient is given during the study will be determined by chance. Findings from this investigation may directly lead to the improvement of symptoms such as: agitation, hostility, suspiciousness, hallucinations, and unusual thoughts. Improved treatment of problematic behaviors and a decrease in medication-associated side effects would enable dementia patients to be cared for in their home environments for longer periods of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Dementia, Vascular
Keywords
Behavioral problems, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Citalopram [Celexa]
Intervention Type
Drug
Intervention Name(s)
Perphenazine [Trilafon]

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for diagnosis of dementia of the Alzheimer's type (AD), Vascular dementia (VD), mixed (AD and VD) or dementia NOS (Not Otherwise Specified) Presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the Neurobehavioral Rating Scale (NBRS) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization Able to participate in study evaluations and ingest oral medication Has next of kin or a guardian available to consent to patient's participation. Exclusion Criteria: Has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially Parkinson's disease) other than dementia Meets DSM-IV criteria for Delirium upon admission to Western Psychiatric Institute and Clinic Has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol) Is currently being treated with cognitive enhancing drugs (Tacrine or Aricept) or any experimental drug Has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression Has preexisting orthostatic hypotension (with > 20 mmHg change from sitting to standing pressure)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce G. Pollock, M.D., Ph.D.
Organizational Affiliation
Western Psychiatric Institute and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Serotonergic Pharmacotherapy for Agitation of Dementia

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