Dichotic Listening as a Predictor of Medication Response in Depression

NCT00296725 | Completed Phase 1 Results

• 3 other identifiers: #4217R/#5294Rcontinuation of IRB3112;became IRB5294R.
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression; Dysthymia; Depressive Disorder Not Otherwise Specified

Keywords

Major Depression; Dysthymia; Depression Not Otherwise Specified; Dichotic Listening; Fluoxetine; Imipramine; Predictors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)

  6 weeks.

Study Arms (1)

fluoxetine / Imipramine

EXPERIMENTAL

fluoxetine or Imipramine

Drug: Fluoxetine; Drug: Imipramine

Interventions

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.

Also known as: Prozac

fluoxetine / Imipramine

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.

Also known as: Tofranil

fluoxetine / Imipramine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18-65
• Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Depression Evaluation Service, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (6)

• 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.

  PMID: 8840353 BACKGROUND

• 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.

  PMID: 11274653 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.

  PMID: 15238992 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.

  PMID: 10609436 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.

  PMID: 2306330 BACKGROUND

• 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.

  PMID: 18061147 DERIVED

Related Links

• Depression Evaluation Service - official website
• New York State Psychiatric Institute - official website

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder

Interventions

Fluoxetine; Imipramine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Open, non-randomized treatment and ratings; small sample size

Results Point of Contact

• Title: Jonathan W. Stewart, M.D., Principle Investigator
• Organization: New York State Psychiatric Institute

jws6@cumc.columbia.edu

646-774-8070

Study Officials

• Jonathan W. Stewart, MD.

  New York State Psychiatric Institute - Columbia University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 27, 2006
• Study Start: April 1, 1994
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 30, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-05

Locations

US (1)