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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).
Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Daily for 12 weeks |
|
| Escitalopram | Experimental | Escitalopram 10 mg or 20 mg daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline | This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression. In this study the score was used as a continuous variable. | MADRS score at baseline |
| Montgomery-Asberg Depression Rating Scale (MADRS) | This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression. In this study the score was used as a continuous variable. | MADRS score at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) - Severity at Baseline | This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7
| Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vani Rao, M.D | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
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| Label | URL |
|---|---|
| Brain Injury Association of Maryland | View source |
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One admitted to active alcohol abuse before initiating medications , and therefore no longer met inclusion criteria. Another consented but failed to return for any follow-up visits.
Subjects were recruited from the Brain injury clinic at Johns Hopkins Bayview Medical Center, other Johns Hopkins outpatient clinics, and via advertisements in local papers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. |
| FG001 | Escitalopram | Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. |
| BG001 | Escitalopram | Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8. |
| 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 (MADRS) at Baseline | This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression. In this study the score was used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | MADRS score at baseline |
|
Through study completion
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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 | Placebo | The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vani Rao | Johns Hopkins University & school of Medicine | 410-550-2288 | vrao@jhmi.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo | Drug | Sugar pill placebo |
|
|
| Clinical Global Impression (CGI)- Improvement | This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. The scores range from 1-7
| at 12 weeks |
| Clinical Anxiety Scale (CAS) | This outcome measure is assessing the participant's anxiety as assessed by the CAS. The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable. | Baseline |
| Clinical Anxiety Scale (CAS) | This outcome measure is assessing the participant's anxiety as assessed by the CAS. The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable. | 12 weeks |
| Satisfaction With Life (SWL) | This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale. The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life). It is used as continuous variable. | baseline |
| Satisfaction With Life (SWL) | This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale. The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life). It is used as continuous variable. | 12 weeks |
| Quality of Life (QWL) | This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale. Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable. | At baseline |
| Quality of Life (QWL) | This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale. Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable. | At 12 weeks |
| Disability Rating Scale (DRS) | This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable. Scores range from 0 (normal) and 29 (extreme vegetative state). | At baseline |
| Disability Rating Scale (DRS) | This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable. Scores range from 0 (normal) and 29 (extreme vegetative state). | At 12 weeks |
| Mini Mental Status Exam (MMSE) | This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal). A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable. | At baseline |
| Mini Mental Status Exam (MMSE) | This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal). A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable. | At 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
|
|
| Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression. In this study the score was used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | MADRS score at 12 weeks |
|
|
|
| Secondary | Clinical Global Impression (CGI) - Severity at Baseline | This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7
| Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Clinical Global Impression (CGI)- Improvement | This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. The scores range from 1-7
| Posted | Mean | Standard Deviation | units on a scale | at 12 weeks |
|
|
|
| Secondary | Clinical Anxiety Scale (CAS) | This outcome measure is assessing the participant's anxiety as assessed by the CAS. The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Clinical Anxiety Scale (CAS) | This outcome measure is assessing the participant's anxiety as assessed by the CAS. The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Satisfaction With Life (SWL) | This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale. The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life). It is used as continuous variable. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Secondary | Satisfaction With Life (SWL) | This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale. The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life). It is used as continuous variable. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Quality of Life (QWL) | This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale. Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | At baseline |
|
|
|
| Secondary | Quality of Life (QWL) | This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale. Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | At 12 weeks |
|
|
|
| Secondary | Disability Rating Scale (DRS) | This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable. Scores range from 0 (normal) and 29 (extreme vegetative state). | Posted | Mean | Standard Deviation | units on a scale | At baseline |
|
|
|
| Secondary | Disability Rating Scale (DRS) | This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable. Scores range from 0 (normal) and 29 (extreme vegetative state). | Posted | Mean | Standard Deviation | units on a scale | At 12 weeks |
|
|
|
| Secondary | Mini Mental Status Exam (MMSE) | This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal). A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | At baseline |
|
|
|
| Secondary | Mini Mental Status Exam (MMSE) | This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal). A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable. | Posted | Mean | Standard Deviation | units on a scale | At 12 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Escitalopram | Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week. | 0 | 8 | 0 | 8 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |