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The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | All patients will receive escitalopram 20 mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D 17). | Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| McGill Quality of Life Scale (MQOL) | McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meera Narasimhan, MD | University of South Carolina School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina School of Medicine | Columbia | South Carolina | 20203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7582177 | Background | Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306. | |
| 10227631 | Background | Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434. |
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Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.
Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label, Single Arm | All patients will receive the intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label, Single Arm | All patients will receive the intervention |
| 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 Scale (HAM-D 17). | Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression. | Intention to Treat | Posted | Median | Standard Deviation | depression severity | 8 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 | Open-label, Single Arm | All patients will receive the intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea vomiting and diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meera Narasimhan, MD | University of South Carolina School of Medicine | 803-434-1100 | shardeman@uscmed.sc.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009103 | Multiple Sclerosis |
| D000690 | Amyotrophic Lateral Sclerosis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
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| 8 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | McGill Quality of Life Scale (MQOL) | McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent). | Posted | Mean | Full Range | quality of life | 8 weeks |
|
|
|
| 0 |
| 14 |
| 5 |
| 14 |
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| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |