Treatment of Depression in the Elderly

This study has been terminated.

Sponsors and Collaborators:	Psychiatric Hospital, Hillerod Psychogeriatric Unit, CU Hospital, Frederiksberg Amager Hospital Psychiatric Center Ballerup,CU Hospital, Ballerup Geriatric Department,Korsør, Vestsjælland
Information provided by:	Psychiatric Hospital, Hillerod
ClinicalTrials.gov Identifier:	NCT00130455

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 IV

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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

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,CU Hospital, Ballerup

Geriatric Department,Korsør, Vestsjælland

Investigators

Principal Investigator:

Alex Koerner, MD

Psychiatric hospital, Hilleroed, Denmark

More Information

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

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Dexetimide

Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009