Treatment of Depression in the Elderly

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00130455
• Other study ID #: HIL-01
• Status: Terminated
• Phase: Phase 4
• First received: August 12, 2005
• Last updated: February 5, 2007
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2007
• Source: Psychiatric Hospital, Hillerod
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 189
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• escitalopram

Locations

Country	Name	City	State
Denmark	Alex Koerner	Hilleroed

Sponsors (5)

Lead Sponsor	Collaborator
Psychiatric Hospital, Hillerod	Amager Hospital, Geriatric Department,Korsør, Vestsjælland, Psychiatric Center Ballerup, Psychogeriatric Unit, CU Hospital, Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4
Primary	Response will be defined as a drop in HAM-D6 score of 50% or more