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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH079414-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Forest Laboratories | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | 12 week open label with 2 week placebo period (14 weeks total) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 20 mg by mouth daily |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 weeks from enrollment (12 weeks from medication start) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 weeks from enrollment (12 weeks from medication start) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Alexopoulos, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College-Westchester Division | White Plains | New York | 10605 | United States |
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106 participants enrolled in the study; however, 35 exited during the 2-week washout period and did not start study medication.
Overall flow of study participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | 12 week open label with 2 week placebo period (14 weeks total) Escitalopram: 20 mg by mouth daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | 12 week open label with 2 week placebo period (14 weeks total) Escitalopram: 20 mg by mouth daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks from enrollment (12 weeks from medication start) |
|
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram | 12 week open label with 2 week placebo period (14 weeks total) Escitalopram: 20 mg by mouth daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation | Surgical and medical procedures | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George S Alexopoulos | Weill Cornell Medicine | 914-997-5767 | gsalexop@med.cornell.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Side Effects |
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| Inter-current medical events |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hamilton Depression Rating Scale (HDRS) 24-Item Total Score | HDRS 24 item: scores can range from 0-76; higher is worse(more depressed) | Mean | Standard Deviation | units on a scale |
|
| Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | MADRS: scores can range from 0-60; higher is worse(more depressed) | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks from enrollment (12 weeks from medication start) |
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|
|
| 0 |
| 71 |
| 3 |
| 71 |
| 47 |
| 71 |
| Anxiety | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Colonoscopy | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Groin infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Hyperparathyroidism | Endocrine disorders | MedDRA (21.1) | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
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| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA (21.1) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |