DepressionPhase 4NCT00130455
Treatment of Depression in the Elderly
A Phase 4 study testing escitalopram in people with Depression, run by Psychiatric Hospital, Hillerod at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression
- What is being tested?
- escitalopram
- How many people
- 189 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Depression
- Being tested
- escitalopram
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startApr 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 189 participants
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital, Hillerod
- Sponsor type
- University, hospital or other
- Collaborators
- Psychogeriatric Unit, CU Hospital, Frederiksberg, Amager Hospital, Psychiatric Center Ballerup, Geriatric Department,Korsør, Vestsjælland
- Investigators
- Alex Koerner, MD, Principal investigator, Psychiatric hospital, Hilleroed, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130455
- Sponsor's protocol ID
- HIL-01
- Status last verified
- Feb 2007
- First submitted
- 12 Aug 2005
- Last updated
- 6 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00130455
- Acronym / sponsor ID
- HIL-01
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 189 participants
- Lead sponsor
- Psychiatric Hospital, HillerodUniversity, hospital or other
- Collaborators
- Psychogeriatric Unit, CU Hospital, Frederiksberg, Amager Hospital, Psychiatric Center Ballerup, Geriatric Department,Korsør, Vestsjælland
- Study start
- Apr 2006
- Study completion
- Jan 2008
- First posted
- 15 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopram | Drug | – |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Koerner, MD principal investigator
Psychiatric hospital, Hilleroed, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram in people with Depression, run by Psychiatric Hospital, Hillerod at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2007; AzTrials last refreshed its copy on 6 Nov 2026.