Depression in the elderly
Conditions
Interventions
Trade Name: Cipralex
Product Name: escitalopram
Product Code: LU 26-054
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Psychiatric Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All in- or out-patients of 65 years of age or above fulfilling the 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). DSM-4 criteria will be registered but will not be used for in- or exclusion • 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 MMSE score of = 17 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 a 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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Primary end point(s): Remission during the study is defined as a HAM-D6 score below 3 Response will be defined as a drop in HAM-D6 score of 50 % or more ;Secondary Objective: 1. To test if the GDS, the GRID HAM-D6 and the AQT are suited as tools to measure change of severity of depression during treatment. 2. To test the validity of self-report version of HAM-D6 in relation to the observer rated version 3. To test if there is difference in efficacy of escitalopram - when used to treat depressive disorders in elderly patients - in relation to pre-existing cognitive dysfunction | — |
Countries
Denmark
Outcome results
None listed