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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH065653-01A1 | 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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | 12-week open label with 2 week placebo period (14 weeks total) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10mg tab daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 14 weeks (12th week of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George S Alexopoulos, MD | Weill Medical College of Cornell University | Principal Investigator |
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116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.
Participant Flow of the Overall Study
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | 12-week open label with 2 week placebo period (14 weeks total) Escitalopram: 10mg tab daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Two Week Drug Washout and Placebo Phase |
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| ||||||||||||||||||
| Treatment Phase |
|
All subjects who entered the treatment phase
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | 12-week open label with 2 week placebo period (14 weeks total) Escitalopram: 10mg tab 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks (12th week of treatment) |
|
|
Up to 14 weeks
Clinicaltrials.gov definitions apply.
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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: 10mg tab daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Alexopoulos, M.D. | Weill Cornell Medical College | 914-997-5767 | galexopoulos@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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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hamilton Scale for Depression | The Hamilton Scale for Depression 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales. | Mean | Standard Deviation | units on a scale |
|
| Mini Mental Status Examination (MMSE) | MMSE total scores range from 0-30. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales. | Mean | Standard Deviation | units on a scale |
|
| WHODAS-II Disability Score | WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales. | Mean | Standard Deviation | units on a scale |
|
| Stroop Color-Word Test | 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. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks (12th week of treatment) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 weeks (12th week of treatment) |
|
|
|
| 0 |
| 90 |
| 6 |
| 90 |
| 55 |
| 90 |
| Depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Colonic hemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Anorgasmia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Prolonged bleeding after a cut | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Edema cerebral | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Edema limbs | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Prolonged gum bleeding | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hyponatremia | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Papulopustular rash | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Homicidal ideation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Vaginal infection | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |