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Treatment of Depression in the Elderly

Primary Purpose

Depression

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Psychiatric Hospital, Hillerod
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alex Koerner

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 12, 2005
Last Updated
February 5, 2007
Sponsor
Psychiatric Hospital, Hillerod
Collaborators
Psychogeriatric Unit, CU Hospital, Frederiksberg, Amager Hospital, Psychiatric Center Ballerup, Geriatric Department,Korsør, Vestsjælland
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1. Study Identification

Unique Protocol Identification Number
NCT00130455
Brief Title
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

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Psychiatric Hospital, Hillerod
Collaborators
Psychogeriatric Unit, CU Hospital, Frederiksberg, Amager Hospital, Psychiatric Center Ballerup, Geriatric Department,Korsør, Vestsjælland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
189 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
escitalopram
Primary Outcome Measure Information:
Title
Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4
Title
Response will be defined as a drop in HAM-D6 score of 50% or more

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Koerner, MD
Organizational Affiliation
Psychiatric hospital, Hilleroed, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alex Koerner
City
Hilleroed
ZIP/Postal Code
DK-3400
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Treatment of Depression in the Elderly

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