Trial | NCT00130455  Report issue

Title

Treatment of Depression in the Elderly
A 12 Week Multi-Centre, Randomized, Double-Blind, Placebo Controlled Evaluation of the Most Efficacious and Tolerable Dose of Escitalopram in the Treatment of Elderly Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    189
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 naturalistic study including all patients of 65 years of age or above that judged by the clinician would benefit from treatment by an antidepressant medication. The study is designed as a double-blind, randomised placebo controlled study with two groups of active treatment (escitalopram in two doses, 5 or 10 mg daily) in a twelve week period.
Study Started
Apr 30
2006
Study Completion
Jan 31
2008
Last Update
Feb 06
2007
Estimate

Drug escitalopram

Criteria 

Inclusion Criteria:

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 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 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
No Results Posted