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Serotonergic Pharmacotherapy for Agitation of Dementia (SPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00009204
Recruitment Status : Completed
First Posted : January 24, 2001
Last Update Posted : June 16, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bruce Pollock, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Dementia, Vascular Drug: Citalopram [Celexa] Drug: Perphenazine [Trilafon] Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Serotonergic Pharmacotherapy for Agitation of Dementia
Study Start Date : September 1995
Actual Primary Completion Date : April 2000
Actual Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00009204

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United States, Pennsylvania
University of Pittsburgh Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Bruce Pollock
National Institute of Mental Health (NIMH)
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Principal Investigator: Bruce G. Pollock, M.D., Ph.D. Western Psychiatric Institute and Clinic

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Responsible Party: Bruce Pollock, Professor, University of Pittsburgh Identifier: NCT00009204     History of Changes
Obsolete Identifiers: NCT00000184
Other Study ID Numbers: R01MH059666-01 ( U.S. NIH Grant/Contract )
R01MH059666-01 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2001    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Bruce Pollock, University of Pittsburgh:
Behavioral problems
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action