Clinical trial NCT00130455: Treatment of Depression in the Elderly
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Psychiatric Hospital, Hillerod
Sponsor class: OTHER
Collaborators: name: Psychogeriatric Unit, CU Hospital, Frederiksberg
name: Amager Hospital
name: Psychiatric Center Ballerup
name: Geriatric Department,Korsør, Vestsjælland
First posted: 2005-08-15
Enrollment: 189
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4
measure: Response will be defined as a drop in HAM-D6 score of 50% or more
Secondary outcomes:
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: Alex Koerner
Study officials:
affiliation: Psychiatric hospital, Hilleroed, Denmark
name: Alex Koerner, MD
role: PRINCIPAL_INVESTIGATOR
References: