DepressionERPNCT00754936
Treatment Response of Geriatric Depression
A study testing Escitalopram in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis: Major depression, unipolar without psychotic features (by DSM-IV criteria) -Severity of depression: A 24-Item HDRS above 19 at screening and at baseline -
- Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores - one half of the sample < 26, one of half ≥ 26.
- Capacity to provide informed consent.
Who cannot join
- High suicide risk, i.e. intent or plan to attempt suicide in near future
- Presence of any current Axis I psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
- Axis II diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (DSM-IV)
- History of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
- Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV
- Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal
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- Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases i.e. MS
- History of failure to respond to escitalopram (Lexapro) (20mg/day for 6 weeks or longer) during the current or previous depressive episodes
- History of intolerance to escitalopram (Lexapro) or use of concomitant drugs that may provide reason to believe that escitalopram is contraindicated. Active treatment with fluoxetine at the time of screening
- Patients' unwillingness or inability to gradually withdraw all other psychotropic medications (except for the following: Low and stable doses of opiates and non-benzodiazepine hypnotics (e.g. zolpidem (5 or 10 mg), zaleplon (5 or 10 mg), or eszopiclone (1 or 2 mg).Low and stable doses of diazepam and other anxiolytics should be tapered at screening; inability to tolerate taper is not an exclusion criteria.
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion
- Inability to speak English
- Aphasia
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College-Westchester Division
White Plains, New York, 10605
About this study
Official title: ERPs, Cognitive Dysfunction and Treatment Response of Geriatric Depression
The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity will be assessed using electrophysiological tests. Researchers are interested in whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them will improve with antidepressant treatment and to what extent. They will also determine whether patients' brain electrical activity during the 12 weeks of medication treatment will change in any way and whether this change will be linked with a change in the severity of their depression. Researchers hope that information gained from this study will help to better understand the brain processes associated with depression and its successful treatment.
Read the detailed description
This research study will examine how the brain electrical activity of elderly depressed patients is related to how quickly and how well they respond to antidepressant medication treatment. Brain electrical activity will be assessed using electrophysiological tests. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Before they start treatment, patients will be asked questions about their depression to measure how severe it is. They will also be asked to have their brain electrical activity recorded while they perform tests on a computer screen. The questions about their depression and the brain electrical recordings will be repeated regularly during the 12 weeks they will be treated with antidepressant medication. The researchers are interested to see whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them and to what extent will finally improve with treatment with escitalopram (Lexapro). They will also determine whether patients' brain electrical activity, during the 12 weeks they will be receiving the medication treatment, will change in any way and whether this change will be linked with the change in the severity of their depression. It is hoped that information gained from this study will help the investigators to better understand the brain processes associated with depression and its successful treatment.
- Conditions
- Depression
- Being tested
- Escitalopram
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
20 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | 12 week open label with 2 week placebo period (14 weeks total) Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (Depression Severity)
A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Measured: 14 weeks from enrollment (12 weeks from medication start)
Secondary outcomes (1)
Hamilton Depression Rating Scale (Depression Severity)
A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Measured: 14 weeks from enrollment (12 weeks from medication start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- George Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754936
- Sponsor's protocol ID
- 0703009061
- Other IDs
- R01MH079414-01A1
- Acronym
- ERP
- Status last verified
- Feb 2019
- First submitted
- 17 Sep 2008
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERPs, Cognitive Dysfunction and Treatment Response of Geriatric Depression
- ClinicalTrials.gov ID
- NCT00754936
- Acronym / sponsor ID
- ERP / 0703009061
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Forest Laboratories
- Study start
- May 2007 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the relationship between brain electrical activity in elderly depressed patients and response to antidepressant medication treatment. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Brain electrical activity will be assessed using electrophysiological tests. Researchers are interested in whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them will improve with antidepressant treatment and to what extent. They will also determine whether patients' brain electrical activity during the 12 weeks of medication treatment will change in any way and whether this change will be linked with a change in the severity of their depression. Researchers hope that information gained from this study will help to better understand the brain processes associated with depression and its successful treatment.
Detailed description
This research study will examine how the brain electrical activity of elderly depressed patients is related to how quickly and how well they respond to antidepressant medication treatment. Brain electrical activity will be assessed using electrophysiological tests. Elderly patients with depression will be treated for 12 weeks with an antidepressant medication commonly used in clinical practice called escitalopram (Lexapro). Before they start treatment, patients will be asked questions about their depression to measure how severe it is. They will also be asked to have their brain electrical activity recorded while they perform tests on a computer screen. The questions about their depression and the brain electrical recordings will be repeated regularly during the 12 weeks they will be treated with antidepressant medication. The researchers are interested to see whether the brain electrical activity of elderly people with depression before they start the medication can tell us who amongst them and to what extent will finally improve with treatment with escitalopram (Lexapro). They will also determine whether patients' brain electrical activity, during the 12 weeks they will be receiving the medication treatment, will change in any way and whether this change will be linked with the change in the severity of their depression. It is hoped that information gained from this study will help the investigators to better understand the brain processes associated with depression and its successful treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram12 week open label with 2 week placebo period (14 weeks total) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis: Major depression, unipolar without psychotic features (by DSM-IV criteria) -Severity of depression: A 24-Item HDRS above 19 at screening and at baseline -
- Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores - one half of the sample < 26, one of half ≥ 26.
- Capacity to provide informed consent.
Key exclusion criteria (13 listed)
- High suicide risk, i.e. intent or plan to attempt suicide in near future
- Presence of any current Axis I psychiatric disorder (other than unipolar major depression or specific phobias) including substance abuse (those with a history of substance abuse must be abstinent for at least 3 months prior to entry)
- Axis II diagnosis of antisocial personality disorder, mental retardation and pervasive developmental disorder (DSM-IV)
- History of psychiatric disorders such as psychotic depression, primary psychotic disorder, or bipolar spectrum disorder (bipolar disorder and hypomania are exclusions)
- Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV
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 |
|---|---|---|
| EscitalopramAlso: Lexapro20 mg by mouth daily | Drug | Escitalopram |
Primary outcome
Montgomery Asberg Depression Rating Scale (Depression Severity)
Time frame: 14 weeks from enrollment (12 weeks from medication start)
A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
1 secondary outcome
Hamilton Depression Rating Scale (Depression Severity)
Time frame: 14 weeks from enrollment (12 weeks from medication start)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
George Alexopoulos, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
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 13 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: finished, as of the sponsor's last update on 19 Mar 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Montgomery Asberg Depression Rating Scale (Depression Severity) (time frame: 14 weeks from enrollment (12 weeks from medication start)). 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 19 Mar 2019.