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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain
This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called Escitalopram(trade name: Lexapro).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depressed Subjects Age: 18 - 25 yrs | Other | Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25 |
|
| Depressed Subjects Age: 16 - 50 yrs | Other | Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10 mg of Escitalopram by mouth once a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 17-item Hamilton Depression Rating Scale (HAM-D) | Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Anand, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Adult Psychiatric Clinic | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Depressed Subjects Age: 18 - 25 Yrs | Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25 Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks |
| FG001 | Depressed Subjects Age: 16 - 50 Yrs | Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50 Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Depressed Subjects Age: 18 - 25 Yrs | Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25 Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks |
| BG001 | Depressed Subjects Age: 16 - 50 Yrs |
| 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 | 17-item Hamilton Depression Rating Scale (HAM-D) | Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 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 | Subjects Age: 18 - 25 | Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25 Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervousness | Psychiatric disorders | Non-systematic Assessment |
Small number of subjects were studied
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Anand MD | Indiana Uiniveristy | 3172747422 | aanand@iupui.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50 Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Subjects Age: 26 - 50 | Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50 Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks | 0 | 11 | 11 | 11 |
| Twitching | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diaarhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weakness or Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Postural hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Increased sleep | Nervous system disorders | Non-systematic Assessment |
|
| Decreased sleep | Nervous system disorders | Non-systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Flushing | Cardiac disorders | Non-systematic Assessment |
|
| Edema | Cardiac disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorgasmia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Increased libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| decreased libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |