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CompletedPhase 4

Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia

Asset

Citalopram

Listed sites

2

Recruiting sites

-

Enrollment

22

estimated

Study population

Frontotemporal dementia

Key I/E criterion

•Age ≥18

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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

Secondary07-48
Org study ID218-2006
NCT IDNCT00376051

Timeline

Milestones

Study start2006-09 (month precision)
Study first posted2006-09-14estimated
Primary completion2009-07actual (month precision)
Study completion2009-09actual (month precision)
Last update posted2017-05-05actual

Assets

Drug assets

Citalopram

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Meet the DSM-IV criteria for primary degenerative dementia
•Meet standard clinical criteria for frontotemporal dementia (ie., frontotemporal degeneration including both the frontal/behavioural variant and primary progressive aphasia)
•Have significant behavioural problems as demonstrated by a score of at least eight on the Neuropsychiatric Inventory (NPI) an
•An independent clinical decision to receive psychotropic medication for behavioural disorders

Exclusion criteria

•An abnormal biochemical screening (blood cell count, vitamin B12 or thyroid function tests)
•Significant medical illness or other medical/neurological conditions which diminish cognitive function (including: drug overdose, severely disturbed liver, kidney, lung or heart function, anemia, hypothyroidism, vitamin B12 or folic acid deficiency, syphilis, uncontrolled diabetes, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumour, subdural hematoma, multiple sclerosis, or brain trauma);
•An Hachinski ischemic score ≥444;
•Electrocardiographic, laboratory or physical evidence of significant cardiovascular disease;
•Hypertension >160 mmHg systolic or >100 mmHg diastolic;
•A brain computed tomographic scan that could not be interpreted as consistent with FTLD;
•Presence of premorbid or current psychiatric diagnosis (including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour such as command hallucinations to harm people or persecutory delusions that provoke violent reactions, psychoactive substance abuse or dependence);
•Contraindications to receiving citalopram (such as concomitant MAOI or within 2 weeks, or hypersensitivity to citalopram); or
•Ongoing need for psychotropic medications (i.e., unsuitable for washout) or administration of a depot antipsychotic injection within one treatment cycle of visit 1

Endpoints (6)

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.

Coverage by outcome category

Behavior / neuropsychiatric
2
Other (unclassified)
2
Function / daily living
1
Other clinical outcomes
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Disability Assessment for Dementia Scale (DAD)

Time frame:Baseline, 4 weeks and 6 weeks

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Screening, Baseline, 4 weeks and 6 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Cornell Scale for Depression in Dementia

Time frame:Baseline, 4 weeks and 6 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Clinical Global Impression (CGI)

Time frame:Screening, 4 week, 6 week

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Frontal Behavioural Inventory (FBI)

Time frame:Baseline, 4 weeks, 6 weeks

descriptive

Secondary/protocol endpoint/low confidence

Functional Assessment Staging (FAST)

Time frame:Baseline, 4 weeks and 6 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.