Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00376051
• Date of registration: 13/09/2006
• Prospective Registration: No
• Primary sponsor: Sunnybrook Health Sciences Centre
• Public title: Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia
• Scientific title: Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia
• Date of first enrolment: September 2006
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00376051
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Nathan Herrmann, MD
• Affiliation: Sunnybrook Health Sciences Centre

• Name: Krista Lanctot, PhD
• Affiliation: Sunnybrook Health Sciences Centre

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Intervention(s)

Drug: Citalopram

Primary Outcome(s)

Neuropsychiatric Inventory (NPI) [Time Frame: Screening, Baseline, 4 weeks and 6 weeks]

Secondary Outcome(s)

Disability Assessment for Dementia Scale (DAD) [Time Frame: Baseline, 4 weeks and 6 weeks]

Clinical Global Impression (CGI) [Time Frame: Screening, 4 week, 6 week]

Functional Assessment Staging (FAST) [Time Frame: Baseline, 4 weeks and 6 weeks]

Cornell Scale for Depression in Dementia [Time Frame: Baseline, 4 weeks and 6 weeks]

Frontal Behavioural Inventory (FBI) [Time Frame: Baseline, 4 weeks, 6 weeks]

Secondary ID(s)

218-2006

07-48

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alzheimer Society of Canada