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
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.
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.
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 →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.
Exclusion Criteria:
12 week open label with 2 week placebo period (14 weeks total)
Drug: Escitalopram
20 mg by mouth daily
Also known as: Lexapro
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)
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)
Overall flow of study participants
| Milestone | Escitalopram |
|---|---|
| Started | 71 |
| Completed | 59 |
| Not completed | 12 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Side effects | 3 |
| Withdrew: Inter-current medical events | 3 |
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.
| units on a scale | Escitalopram |
|---|---|
| Montgomery Asberg Depression Rating Scale (Depression Severity) | 12.23 ± 7.67 |
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.
| units on a scale | Escitalopram |
|---|---|
| Hamilton Depression Rating Scale (Depression Severity) | 11.47 ± 6.64 |
Collected over 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Escitalopram | 0/71 (0%) | 3/71 (4.2%) | 47/71 (66.2%) |
| Event | Escitalopram |
|---|---|
| HospitalisationSurgical and medical procedures | 3/71 |
| Event | Escitalopram |
|---|---|
| FallInjury, poisoning and procedural complications | 21/71 |
| DiarrhoeaGastrointestinal disorders | 12/71 |
| DizzinessNervous system disorders | 3/71 |
| Burning sensationNervous system disorders | 2/71 |
| NauseaGastrointestinal disorders | 2/71 |
| RashSkin and subcutaneous tissue disorders | 2/71 |
| SinusitisInfections and infestations | 2/71 |
| Upper respiratory tract infectionInfections and infestations | 2/71 |
| Abdominal pain upperGastrointestinal disorders | 1/71 |
| AnxietyPsychiatric disorders | 1/71 |
| Age, Categorical(Participants) | Escitalopram |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 58 |
| Age, Continuous(years) | Escitalopram |
|---|---|
| Mean | 71.91 ± 7.53 |
| Sex: Female, Male(Participants) | Escitalopram |
|---|---|
| Female | 36 |
| Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Escitalopram |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 67 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Escitalopram |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 66 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Escitalopram |
|---|---|
| United States | 71 |
| Hamilton Depression Rating Scale (HDRS) 24-Item Total Score(units on a scale) | Escitalopram |
|---|---|
| Mean | 23.83 ± 4.48 |
| Montgomery and Asberg Depression Rating Scale (MADRS) Total Score(units on a scale) | Escitalopram |
|---|---|
| Mean | 24.08 ± 5.74 |
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Weill Medical College of Cornell University