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
  Purpose

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.


Condition Intervention Phase
Depression
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Psychiatric Hospital, Hillerod:

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

Estimated Enrollment: 189
Study Start Date: April 2006
Estimated Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130455

Locations
Denmark
Alex Koerner
Hilleroed, Denmark, DK-3400
Sponsors and Collaborators
Psychiatric Hospital, Hillerod
Psychogeriatric Unit, CU Hospital, Frederiksberg
Amager Hospital
Psychiatric Center Ballerup
Geriatric Department,Korsør, Vestsjælland
Investigators
Principal Investigator: Alex Koerner, MD Psychiatric hospital, Hilleroed, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130455     History of Changes
Other Study ID Numbers: HIL-01
Study First Received: August 12, 2005
Last Updated: February 5, 2007
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014