Treatment of Depression in the Elderly

NCT ID: NCT00130455

Last Updated: 2007-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-01-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

escitalopram

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psychogeriatric Unit, CU Hospital, Frederiksberg

UNKNOWN

Sponsor Role: collaborator

Amager Hospital

OTHER

Sponsor Role: collaborator

Psychiatric Center Ballerup

OTHER

Sponsor Role: collaborator

Geriatric Department,Korsør, Vestsjælland

UNKNOWN

Sponsor Role: collaborator

Psychiatric Hospital, Hillerod

OTHER

Sponsor Role: lead

Principal Investigators

Alex Koerner, MD

Role: PRINCIPAL_INVESTIGATOR

Psychiatric hospital, Hilleroed, Denmark

Locations

Alex Koerner

Hilleroed, , Denmark

Countries

Denmark

Other Identifiers

HIL-01

Identifier Type: -

Identifier Source: org_study_id