CClinicalTrials.gg
TerminatedNCT00130455Updated Feb 6, 2007

Treatment of Depression in the Elderly

A Phase 4 interventional study of escitalopram in Depression, sponsored by Psychiatric Hospital, Hillerod. Terminated at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2007-02-06.

Sponsored by Psychiatric Hospital, Hillerod · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 189 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Psychiatric Hospital, Hillerod as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
189 participants

Interventions

  • Drugescitalopram
06

What researchers measure

Primary outcomes

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

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

07

Study locations

1 site
  • Alex Koerner
    Hilleroed, DK-3400, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00130455
Lead sponsor
Psychiatric Hospital, Hillerod
Collaborators
Psychogeriatric Unit, CU Hospital, Frederiksberg, Amager Hospital, Psychiatric Center Ballerup, Geriatric Department,Korsør, Vestsjælland
First posted
Aug 15, 2005
Start date
Apr 2006
Completion
Jan 2008
Last update
Feb 6, 2007

Study contacts

Alex Koerner, MD
principal investigator · Psychiatric hospital, Hilleroed, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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