Status:
TERMINATED
Treatment of Depression in the Elderly
Lead Sponsor:
Psychiatric Hospital, Hillerod
Collaborating Sponsors:
Psychogeriatric Unit, CU Hospital, Frederiksberg
Amager Hospital
Conditions:
Depression
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The study is designed to establish the efficacy and tolerability of escitalopram in the treatment of depressive episodes of mild to moderate severity in the elderly. The study is designed as a mainly...
Eligibility Criteria
Inclusion
- In- or out-patients of 65 years of age or above fulfilling the International Classification of Diseases-Tenth Edition (ICD-10) diagnosis of depressive single episode (F32.00-32.11. 32.8 or 32.9), depressive recurrent episode (F33.00-33.11, 33.8 or 33.9) or organic depressive episode (F06.32).
- The depressive state should be mild to moderate and reach a score on HAM-D6 of ≥ 7 and ≤ 11
- Patients with dementia can be included provided they have a mini mental state exam (MMSE) score of ≥ 17
Exclusion
- Patients with a current depressive episode of a severity reaching a score of ≥ 12 on the HAM-D6-item depression factor. This is to exclude patients with severe or psychotic depression
- Patients with suicidal thoughts or behaviour
- Patients with conditions where treatment with escitalopram is contraindicated: e.g. hypersensitivity to escitalopram or other contents of escitalopram tablets, concomitant treatment with non-selective, irreversible mono-amine-oxidase inhibitors, such as Marplan
- Patients who in the current depressive episode have had a failed trial of treatment with escitalopram
- Co-morbid dementia with a severity corresponding to a score on the MMSE of less than 17 as these patients will often be without the ability to give informed consent
- Patients with sensory defects rendering psychometric assessment impossible, e.g. deafness, blindness, severe aphasia
- Patients who cannot speak Danish well enough to make psychometric assessment possible and meaningful
- Patients with congenital or early acquired intellectual deficits
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00130455
Start Date
April 1 2006
End Date
January 1 2008
Last Update
February 6 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alex Koerner
Hilleroed, Denmark, DK-3400