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| ID | Type | Description | Link |
|---|---|---|---|
| continuation of IRB3112; | Other Grant/Funding Number | There is no grantor or funder | |
| became IRB5294R. | Other Grant/Funding Number | there is no grantor or funder |
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Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.
100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluoxetine / Imipramine | Experimental | fluoxetine or Imipramine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating "remission" and scores that have decreased >= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1="No psychopathology" 2="Minimal psychopathology" 3="Mild psychopathology 4="Moderate psychopathology" 5="Moderately severe psychopathology" 6="Severe psychopathology" 7 "Extreme psychopathology". CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1="Very much improved" 2="much improved" 3="minimally improved" 4="Unchanged" 5="minimally worse" 6="much worse" 7="very much worse". Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define "response" as a CGI-I of 1 or 2; "nonresponse" is all other ratings (i.e., CGI-I = 3 or higher. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan W. Stewart, MD. | New York State Psychiatric Institute - Columbia University Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Evaluation Service, New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8840353 | Background | Bruder GE, Otto MW, McGrath PJ, Stewart JW, Fava M, Rosenbaum JF, Quitkin FM. Dichotic listening before and after fluoxetine treatment for major depression: relations of laterality to therapeutic response. Neuropsychopharmacology. 1996 Aug;15(2):171-9. doi: 10.1016/0893-133X(95)00180-L. | |
| 11274653 | Background |
| Label | URL |
|---|---|
| Depression Evaluation Service - official website | View source |
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17 participants available and eligible to participate in period I
25 Screened. 4 did not return, 2 withdrew consent. Period 1 started with 17 participants available and eligible to participate in period I were treated with fluoxetine; 2 fluoxetine non-responders, 3 non-remiiters and 3/5 dropouts (n=8) continued to Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoxetine / Imipramine | Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated. Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Fluoxetine (1-12 Weeks) |
|
| |||||||||||||||||||||
| Phase 2: Imipramine (1-6 Weeks) |
|
Baseline data collected for all 25 enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoxetine / Imipramine | Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated. Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated. |
| 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) | The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating "remission" and scores that have decreased >= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | 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 | Fluoxetine | fluoxetine Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment | feeling short of breath |
Open, non-randomized treatment and ratings; small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan W. Stewart, M.D., Principle Investigator | New York State Psychiatric Institute | 646-774-8070 | jws6@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D003984 | Dibenzazepines |
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|
| Imipramine | Drug | Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated. |
|
|
| 6 weeks. |
| Bruder GE, Stewart JW, Tenke CE, McGrath PJ, Leite P, Bhattacharya N, Quitkin FM. Electroencephalographic and perceptual asymmetry differences between responders and nonresponders to an SSRI antidepressant. Biol Psychiatry. 2001 Mar 1;49(5):416-25. doi: 10.1016/s0006-3223(00)01016-7. |
| 15238992 | Background | Bruder GE, Stewart JW, McGrath PJ, Deliyannides D, Quitkin FM. Dichotic listening tests of functional brain asymmetry predict response to fluoxetine in depressed women and men. Neuropsychopharmacology. 2004 Sep;29(9):1752-61. doi: 10.1038/sj.npp.1300519. |
| 10609436 | Background | Stewart JW, Quitkin FM, McGrath PJ, Bruder GE. Do tricyclic responders have different brain laterality? J Abnorm Psychol. 1999 Nov;108(4):707-10. doi: 10.1037//0021-843x.108.4.707. |
| 2306330 | Background | Bruder GE, Stewart JW, Voglmaier MM, Harrison WM, McGrath P, Tricamo E, Quitkin FM. Cerebral laterality and depression: relations of perceptual asymmetry to outcome of treatment with tricyclic antidepressants. Neuropsychopharmacology. 1990 Feb;3(1):1-10. |
| 18061147 | Derived | Bruder GE, Sedoruk JP, Stewart JW, McGrath PJ, Quitkin FM, Tenke CE. Electroencephalographic alpha measures predict therapeutic response to a selective serotonin reuptake inhibitor antidepressant: pre- and post-treatment findings. Biol Psychiatry. 2008 Jun 15;63(12):1171-7. doi: 10.1016/j.biopsych.2007.10.009. Epub 2007 Dec 3. |
| New York State Psychiatric Institute - official website | View source |
|
| Participants |
|
| Age, Continuous | Age in years as reported by subject | 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 |
|
| OG001 | Imipramine | imipramine Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated. |
|
|
| Secondary | Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1="No psychopathology" 2="Minimal psychopathology" 3="Mild psychopathology 4="Moderate psychopathology" 5="Moderately severe psychopathology" 6="Severe psychopathology" 7 "Extreme psychopathology". CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1="Very much improved" 2="much improved" 3="minimally improved" 4="Unchanged" 5="minimally worse" 6="much worse" 7="very much worse". Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define "response" as a CGI-I of 1 or 2; "nonresponse" is all other ratings (i.e., CGI-I = 3 or higher. | Response Rate | Posted | Count of Participants | Participants | 6 weeks. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 7 |
| 17 |
| EG001 | Imipramine | imipramine Imipramine: wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated. | 0 | 8 | 0 | 8 | 1 | 8 |
|
| irritability | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | patient reports feeling irritable |
|
| rash | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment | urticaria |
|
| lost to follow-up | General disorders | MedDRA (10.0) | Non-systematic Assessment | Patient did not return for regular visits and did not respond to telephone messages or letters |
|
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| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |