CClinicalTrials.gg
CompletedNCT00754936ERPUpdated Mar 19, 2019Results posted

Treatment Response of Geriatric Depression

An interventional study of Escitalopram in Depression, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2007, registered Sep 2008).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Not applicable
Ages
60 Years to 90 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Depression

Keywords

  • Depression
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 106 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Escitalopram

    12 week open label with 2 week placebo period (14 weeks total)

    Drug: Escitalopram

Interventions

  • DrugEscitalopram

    20 mg by mouth daily

    Also known as: Lexapro

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 14 weeks from enrollment (12 weeks from medication start)

07

Results

Posted Mar 19, 2019

Participant flow

Overall flow of study participants

Participant flow — Overall Study
MilestoneEscitalopram
Started71
Completed59
Not completed12
Withdrew: Lost to follow-up3
Withdrew: Physician decision1
Withdrew: Withdrawal by subject2
Withdrew: Side effects3
Withdrew: Inter-current medical events3

Outcome measures

PrimaryMontgomery 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.

Time frame:
14 weeks from enrollment (12 weeks from medication start)
Reported as:
Mean · units on a scale
Montgomery Asberg Depression Rating Scale (Depression Severity)
units on a scaleEscitalopram
Montgomery Asberg Depression Rating Scale (Depression Severity)12.23 ± 7.67
SecondaryHamilton 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.

Time frame:
14 weeks from enrollment (12 weeks from medication start)
Reported as:
Mean · units on a scale
Hamilton Depression Rating Scale (Depression Severity)
units on a scaleEscitalopram
Hamilton Depression Rating Scale (Depression Severity)11.47 ± 6.64

Adverse events

Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Escitalopram0/71 (0%)3/71 (4.2%)47/71 (66.2%)
Most frequent serious events
Most frequent serious events
EventEscitalopram
HospitalisationSurgical and medical procedures3/71
Most frequent other events
Showing 10 of 33
Most frequent other events
EventEscitalopram
FallInjury, poisoning and procedural complications21/71
DiarrhoeaGastrointestinal disorders12/71
DizzinessNervous system disorders3/71
Burning sensationNervous system disorders2/71
NauseaGastrointestinal disorders2/71
RashSkin and subcutaneous tissue disorders2/71
SinusitisInfections and infestations2/71
Upper respiratory tract infectionInfections and infestations2/71
Abdominal pain upperGastrointestinal disorders1/71
AnxietyPsychiatric disorders1/71

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Escitalopram
<=18 years0
Between 18 and 65 years13
>=65 years58
Age, Continuous
Age, Continuous(years)Escitalopram
Mean71.91 ± 7.53
Sex: Female, Male
Sex: Female, Male(Participants)Escitalopram
Female36
Male35
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Escitalopram
Hispanic or Latino4
Not Hispanic or Latino67
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Escitalopram
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American4
White66
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Escitalopram
United States71
Hamilton Depression Rating Scale (HDRS) 24-Item Total Score
Hamilton Depression Rating Scale (HDRS) 24-Item Total Score(units on a scale)Escitalopram
Mean23.83 ± 4.48
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score(units on a scale)Escitalopram
Mean24.08 ± 5.74
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Study locations

1 site
  • Weill Cornell Medical College-Westchester Division
    White Plains, New York 10605, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00754936
Lead sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), Forest Laboratories
Responsible party
Sponsor
First posted
Sep 18, 2008
Start date
May 2007
Primary completion
May 2015
Completion
May 2015
Results posted
Mar 19, 2019
Last update
Mar 19, 2019

Study contacts

George Alexopoulos, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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