DepressionPhase 4FANCT00918684
Aging Brain Changes, Executive Dysfunction and Depression
A Phase 4 study testing Escitalopram in people with Depression, run by Weill Medical College of Cornell University.
Trial summary
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to May 2010
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
- Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
- Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).
Who cannot join
- Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
- High suicide risk, i.e. intent or plan to attempt suicide in near future.
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
- Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
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- 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.
- Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.
- Current involvement in psychotherapy.
- History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
- 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.
- Residence outside a 45-minute drive from Cornell's clinical facilities.
- Patients taking MAOI's and Fluoxetine will be excluded.
About this study
Official title: Aging White Matter Changes, Executive Dysfunction and Depression
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.
Read the detailed description
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
- 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
10mg tab 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.
Hamilton Depression Rating Scale.
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 (12th week of treatment)
WHODAS-II Disability Scale
A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Measured: 14 weeks (12th week of treatment)
Stroop Color-Word Test
A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
Measured: 14 weeks (12th week of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startDec 2002
- Primary completionMay 2010
- Study completionMay 2010
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 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 S Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918684
- Sponsor's protocol ID
- 0204005523
- Other IDs
- R01MH065653-01A1
- Acronym
- FA
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2009
- Last updated
- 12 May 2017
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging White Matter Changes, Executive Dysfunction and Depression
- ClinicalTrials.gov ID
- NCT00918684
- Acronym / sponsor ID
- FA / 0204005523
- Conditions
- Depression
- Keywords
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Forest Laboratories
- Study start
- Dec 2002 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 12 May 2017
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 look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.
Detailed description
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.
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 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
- Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
- Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).
Key exclusion criteria (15 listed)
- Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
- High suicide risk, i.e. intent or plan to attempt suicide in near future.
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
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: Lexapro10mg tab daily | Drug | Escitalopram |
Primary outcome
Hamilton Depression Rating Scale.
Time frame: 14 weeks (12th week of treatment)
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.
WHODAS-II Disability Scale
Time frame: 14 weeks (12th week of treatment)
A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Stroop Color-Word Test
Time frame: 14 weeks (12th week of treatment)
A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- 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 S Alexopoulos, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Depression, run by Weill Medical College of Cornell University.
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 15 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 May 2017). 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?
Hamilton Depression Rating Scale. (time frame: 14 weeks (12th week of treatment)). The study lists 3 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 12 May 2017.