Treatment of Depression in the Elderly | NCT00130455

Studies
Treatment of Depression in the Elderly

NCT00130455

Sponsor

Psychiatric Hospital, Hillerod

Status

Terminated

Last Update Posted

Feb 6, 2007Estimated

Enrollment

189

Phase

Phase 4

Conditions

Depression

Interventions

escitalopram

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Jan 2008

First Submitted Date

Aug 12, 2005

First Submission Date that Met QC Criteria

Aug 12, 2005

First Posted Date

Aug 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2007

Last Update Posted Date

Feb 6, 2007Estimated

Name	Class
Psychogeriatric Unit, CU Hospital, Frederiksberg	UNKNOWN
Amager Hospital	OTHER
Psychiatric Center Ballerup	OTHER
Geriatric Department,Korsør, Vestsjælland

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189

Name	Type	Description	Arm Group Labels	Other Names
escitalopram	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Measure	Description	Time Frame
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

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572