Treatment of Depression in the Elderly

This study has been terminated.
Sponsor:
Collaborators:
Psychogeriatric Unit, CU Hospital, Frederiksberg
Amager Hospital
Psychiatric Center Ballerup
Geriatric Department,Korsør, Vestsjælland
Information provided by:
Psychiatric Hospital, Hillerod
ClinicalTrials.gov Identifier:
NCT00130455
First received: August 12, 2005
Last updated: February 5, 2007
Last verified: February 2007

August 12, 2005
February 5, 2007
April 2006
Not Provided
  • 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
  • Remission during the study is defined as a HAM-D6 score less than or equal to 4
  • Response will be defined as a drop in HAM-D6 score of 50 % or more
Complete list of historical versions of study NCT00130455 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Treatment of Depression in the Elderly
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
Drug: escitalopram
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
189
January 2008
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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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00130455
HIL-01
Not Provided
Not Provided
Psychiatric Hospital, Hillerod
  • Psychogeriatric Unit, CU Hospital, Frederiksberg
  • Amager Hospital
  • Psychiatric Center Ballerup
  • Geriatric Department,Korsør, Vestsjælland
Principal Investigator: Alex Koerner, MD Psychiatric hospital, Hilleroed, Denmark
Psychiatric Hospital, Hillerod
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP