Treatment of Depression in the Elderly

NCT00130455 | Terminated Phase 4

• 1 other identifier: HIL-01
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4

• Response will be defined as a drop in HAM-D6 score of 50% or more

Interventions

escitalopram DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Hospital, Hillerod: lead
• Psychogeriatric Unit, CU Hospital, Frederiksberg: collaborator
• Amager Hospital: collaborator
• Psychiatric Center Ballerup: collaborator
• Geriatric Department,Korsør, Vestsjælland: collaborator

Study Sites (1)

Alex Koerner

Hilleroed, DK-3400, Denmark

Location

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alex Koerner, MD

  Psychiatric hospital, Hilleroed, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: April 1, 2006
• Study Completion: January 1, 2008
• Last Updated: February 6, 2007

Record last verified: 2007-02

Locations

DK (1)