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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 5294R | Other Grant/Funding Number | There is no grantor or funder |
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This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.
Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| escitalopram | Experimental | escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d |
|
| bupropion | Experimental | bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted |
|
| imipramine | Experimental | imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63. | 6 weeks or last visit in Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale (CGI) | The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse). | 6 weeks or last visit in Phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan W. Stewart, M.D. | New York State Psychiatric Institute | Principal Investigator |
| Gerard Bruder, PhD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| Depression Evaluation Service official website | View source |
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Patients had to have not taken psychotropic medication for at least two weeks (no fluoxetine for at least 5 weeks) and had to produce a urine negative for commonly abused substances. Current use of psychotropic medication or a positive urine toxicology screen would abort further study participation.
Recruitment Period: 7/24/2006 - 4/7/2008 Recruitment Location: outpatient research clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion | this was the initial treatment given to all patients except one who was ineligible for bupropion and received escitalopram bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I (Bupropion) |
|
| |||||||||||||||||||||
| Phase II (Escitalopram) |
| ||||||||||||||||||||||
| Phase III (Imipramine) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion | bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) | Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63. | Participants were included if they were given that medication | Posted | Mean | Standard Deviation | units on a scale | 6 weeks or last visit in Phase |
|
6 weeks
6 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 | escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction | Immune system disorders | drug allergy | Non-systematic Assessment | rash resolved within 48 hours of discontinuing medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | nausea | Non-systematic Assessment | queasy stomach |
This is an open (i.e., unblinded) study having small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan W. Stewart, M.D. | New York State Psychiatric Institute | 646-774-8000 | jws6@columbia.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D016642 | Bupropion |
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| bupropion | Drug | bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d |
|
|
| imipramine | Drug | imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted |
|
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Imipramine | imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted |
|
|
| Secondary | Clinical Global Impression Scale (CGI) | The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse). | Posted | Mean | Standard Deviation | units on a scale | 6 weeks or last visit in Phase |
|
|
|
| 0 |
| 11 |
| 10 |
| 11 |
| EG001 | Bupropion | bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d | 1 | 17 | 10 | 17 |
| EG002 | Imipramine | imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted | 0 | 3 | 3 | 3 |
|
| anorgasmia | Reproductive system and breast disorders | anorgasmia | Non-systematic Assessment | delayed, inability to reach orgasm |
|
| headache | General disorders | headache | Non-systematic Assessment | headache |
|
| overstimulatioin | General disorders | overstimulation | Non-systematic Assessment | too "revved up" |
|
| insomnia | General disorders | insomnia | Non-systematic Assessment | trouble sleeping |
|
| allergic reaction | Immune system disorders | allergic reaction | Non-systematic Assessment | drug allergy |
|
| dry mouth | Gastrointestinal disorders | dry mouth | Non-systematic Assessment | dry mouth |
|
| constipation | Gastrointestinal disorders | constipation | Non-systematic Assessment | hard stool |
|
| a.m. grogginess | General disorders | morning grogginess | Non-systematic Assessment | feeling "drugged" in the morning |
|
| orthostatic hypotension | Cardiac disorders | orthostasis | Non-systematic Assessment | dizziness on standing |
|
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| D001519 |
| Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |