Major DepressionPhase 1/2NCT00296725
Dichotic Listening as a Predictor of Medication Response in Depression
A Phase 1/2 study testing Fluoxetine and Imipramine in people with Major Depression and Dysthymia, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Dysthymia, Depressive Disorder Not Otherwise Specified
- What is being tested?
- Fluoxetine and Imipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1994to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18-65
- Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified
Who cannot join
- Known hearing impairment
- Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis)
- Hamilton Rating Scale for Depression, 17-item version > 20
- Current (past six months) alcohol and/or drug abuse or dependence
- Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
- Bipolar I
Show all 12Show fewer
- Psychosis
- If currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for Prozac) or felt to require other psychiatric medication (other than occasional sleep or Anxiety medication)
- Premenopausal women not using known effective birth control
- Not currently depressed (whether considered due to current treatment or not)
- Nonresponse to adequate trial of both study medications (i.e., > 4weeks on > escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., > 4 weeks on > citalopram 60 mg/d)
- Left-handed
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service, New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Dichotic Listening as a Predictor of Placebo and Medication Response in Depression
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.
Read the detailed description
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.
- Being tested
- Fluoxetine, Imipramine
- Keywords
- Major Depression, Dysthymia, Depression Not Otherwise Specified, Dichotic Listening, Fluoxetine, Imipramine, Predictors
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
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.
ImipramineDrug
Also called Tofranil
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.
| Study group | Role | What they receive |
|---|---|---|
| fluoxetine / Imipramine | Experimental | fluoxetine or Imipramine Receives: Drug: Fluoxetine; Drug: Imipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startApr 1994
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan W Stewart, M.D, New York State Psychiatric Institute
- Investigators
- Jonathan W. Stewart, MD., Principal investigator, New York State Psychiatric Institute - Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296725
- Sponsor's protocol ID
- #4217R/#5294R
- Other IDs
- continuation of IRB3112;, became IRB5294R.
- Status last verified
- May 2019
- First submitted
- 24 Feb 2006
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 8840353Bruder 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.
PubMed 11274653Bruder 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.
PubMed 15238992Stewart 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.
PubMed 10609436Bruder 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.
PubMed 2306330Bruder 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.
PubMed 18061147
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichotic Listening as a Predictor of Placebo and Medication Response in Depression
- ClinicalTrials.gov ID
- NCT00296725
- Acronym / sponsor ID
- #4217R/#5294R
- Keywords
- Major Depression, Dysthymia, Depression Not Otherwise Specified, Dichotic Listening, Fluoxetine, Imipramine, Predictors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Apr 1994
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluoxetine / Imipramine | Experimental | Drug: Fluoxetine, Drug: Imipraminefluoxetine or Imipramine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages between 18-65
- Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified
Key exclusion criteria (12 listed)
- Known hearing impairment
- Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis)
- Hamilton Rating Scale for Depression, 17-item version > 20
- Current (past six months) alcohol and/or drug abuse or dependence
- Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacPhase 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. | Drug | fluoxetine / Imipramine |
| ImipramineAlso: TofranilPhase 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. | Drug | fluoxetine / Imipramine |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: 6 weeks
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.
1 secondary outcome
Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)
Time frame: 6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8840353Bruder 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.
- Background: PubMed 11274653Bruder 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.
- Background: PubMed 15238992Bruder 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.
- Background: PubMed 10609436Stewart 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.
- Background: PubMed 2306330Bruder 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.
- Derived from this study: PubMed 18061147Bruder 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.
- Depression Evaluation Service - official websiteLink provided by the sponsor.
- New York State Psychiatric Institute - official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W. Stewart, MD. principal investigator
New York State Psychiatric Institute - Columbia University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fluoxetine and Imipramine in people with Major Depression and Dysthymia, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (HAM-D) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296725, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.