Phase 2
Completed N=17
Dichotic Listening as a Predictor of Medication Response in Depression
Depression · Dysthymia · Depressive Disorder Not Otherwise Specified
Source: ClinicalTrials.gov NCT00296725 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Hamilton Depression Scale (HAM-D) — 10; 9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Scale (HAM-D) |
10; 9 | — |
| SECONDARY Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) |
7; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Ages between 18-65
- Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00296725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.