Status:
COMPLETED
Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Alzheimer Society of Canada
Conditions:
Frontotemporal Dementia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Frontotemporal lobar degeneration(FTLD) is a common cause of early-onset dementia. FTLD is characterized multiple behavioral symptoms including mental rigidity, irritability, emotional blunting, disin...
Detailed Description
Objectives: A hallmark of frontotemporal lobar degeneration(FTLD) is its associated behavioural disturbances (BPSD), which include disinhibition, aggression, apathy, agitation, depression, and inappro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00376051
Start Date
September 1 2006
End Date
September 1 2009
Last Update
May 5 2017
Active Locations (2)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
2
The Baycrest Centre for Geriatric Care
Toronto, Ontario, Canada, M6A 2E1