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← Trials/Trial dossier/NCT00009204

SPAD

CompletedPhase 3

Serotonergic Pharmacotherapy for Agitation of Dementia

Lead sponsor

Bruce Pollock

Assets

Citalopram / Perphenazine [Trilafon]

Listed sites

1

Recruiting sites

-

Enrollment

-

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criterion

Multiple dementia etiologies

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

SecondaryIA0014
NCT IDNCT00009204
Org study IDR01MH059666-01https://reporter.nih.gov/quickSearch/R01MH059666-01
NihR01MH059666-01

Timeline

Milestones

Study start1995-09 (month precision)
Primary completion2000-04actual (month precision)
Study first posted2001-01-24estimated
Study completion2002-04actual (month precision)
Last update posted2017-06-16actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

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)

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.