Major DepressionPhase 4NCT00296777
Treatment of Depression Following Multiple Brain Tests
A Phase 4 study testing Escitalopram, Bupropion and Imipramine in people with Major Depression and Dysthymia, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The main purpose of this study is to correlate brain testing with treatment outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Dysthymia
- What is being tested?
- Escitalopram, Bupropion and Imipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- DSM-IV Major Depression or Dysthymia
- Age 18-65
- Physically healthy
- Normal hearing
- Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)
Who cannot join
- Hearing deficit in one or both ears
- Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
- History of Psychosis or Epilepsy
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- Unstable medical problem
- Insufficient English for neuropsychological and dichotic testing
Show all 11Show fewer
- Bipolar I
- Need for wash-out from effective treatment in order to participate
- Pregnant
- High suicide risk
- Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
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: Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
The main purpose of this study is to correlate brain testing with treatment outcome.
Read the detailed description
40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.
- Conditions
- Major Depression, Dysthymia
- Being tested
- Escitalopram, Bupropion, Imipramine
- Keywords
- Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening, EEG, ERP
- 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.
EscitalopramDrug
Also called Lexapro
8 weeks: up to 40 mg/day
BupropionDrug
Also called Wellbutrin
8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
ImipramineDrug
Also called Tofranil, Pressamine
8 weeks: up to 300mg/day
*if patient does not have contraindication.
| Study group | Role | What they receive |
|---|---|---|
| escitalopram | Experimental | escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d Receives: Drug: Escitalopram |
| bupropion | Experimental | bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d Receives: Drug: Bupropion |
| imipramine | Experimental | imipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, all dose increases if tolerated and not remitted Receives: Drug: Imipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: 7 mos.
Secondary outcomes (7)
Beck Depression Inventory (BDI)
Measured: 7 mos.
Clinical Global Impression (CGI)
Measured: 7 mos.
Patient Global Impression (PGI)
Measured: 7 mos.
Inventory of Depressive Symptoms (IDS)
Measured: 7 mos.
Edinburgh Handedness Inventory
Measured: 7 mos.
Chapman Pleasure Scale
Measured: 7 mos.
Spielberger State/Trait Anxiety Inventory
Measured: 7 mos.
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 startDec 2004
- Primary completionMay 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W. Stewart, MD., Principal investigator, New York State Psychiatric Institute - Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296777
- Sponsor's protocol ID
- #4781
- Status last verified
- Apr 2012
- First submitted
- 23 Feb 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor BP, Bruder GE, Stewart JW, McGrath PJ, Halperin J, Ehrlichman H, Quitkin FM. Psychomotor slowing as a predictor of fluoxetine nonresponse in depressed outpatients. Am J Psychiatry. 2006 Jan;163(1):73-8. doi: 10.1176/appi.ajp.163.1.73.
PubMed 16390892Bruder 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, 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 8840353Stewart 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, 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 15238992
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
- ClinicalTrials.gov ID
- NCT00296777
- Acronym / sponsor ID
- #4781
- Conditions
- Major Depression, Dysthymia
- Keywords
- Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to correlate brain testing with treatment outcome.
Detailed description
40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| escitalopram | Experimental | Drug: Escitalopramescitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d |
| bupropion | Experimental | Drug: Bupropionbupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d |
| imipramine | Experimental | Drug: Imipramineimipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, all dose increases if tolerated and not remitted |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV Major Depression or Dysthymia
- Age 18-65
- Physically healthy
- Normal hearing
- Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)
Key exclusion criteria (11 listed)
- Hearing deficit in one or both ears
- Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
- History of Psychosis or Epilepsy
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- Unstable medical problem
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 |
|---|---|---|
| EscitalopramAlso: Lexapro8 weeks: up to 40 mg/day | Drug | escitalopram |
| BupropionAlso: Wellbutrin8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures. | Drug | bupropion |
| ImipramineAlso: Tofranil, Pressamine8 weeks: up to 300mg/day *if patient does not have contraindication. | Drug | imipramine |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: 7 mos.
7 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: 7 mos.
Clinical Global Impression (CGI)
Time frame: 7 mos.
Patient Global Impression (PGI)
Time frame: 7 mos.
Inventory of Depressive Symptoms (IDS)
Time frame: 7 mos.
Edinburgh Handedness Inventory
Time frame: 7 mos.
Chapman Pleasure Scale
Time frame: 7 mos.
Spielberger State/Trait Anxiety Inventory
Time frame: 7 mos.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- Background: PubMed 16390892Taylor BP, Bruder GE, Stewart JW, McGrath PJ, Halperin J, Ehrlichman H, Quitkin FM. Psychomotor slowing as a predictor of fluoxetine nonresponse in depressed outpatients. Am J Psychiatry. 2006 Jan;163(1):73-8. doi: 10.1176/appi.ajp.163.1.73.
- 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.
- 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 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 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.
- 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 4 study testing Escitalopram, Bupropion 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 5 inclusion and 11 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 27 Apr 2012. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 7 mos.). 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 NCT00296777, 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 27 Apr 2012.