Treatment of Depression in the Elderly
This study has been terminated.
Sponsor:
Psychiatric Hospital, Hillerod
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
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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
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 Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013