Phase 4
N=17
Dichotic Listening as a Predictor of Medication Response in Depression
Major Depressive Disorder · Dysthymia
Bottom Line
View on ClinicalTrials.gov: NCT00404755 ↗Enrolled (actual)
17
Serious AEs
3.2%
Results posted
Mar 2018
Primary outcome: Primary: Hamilton Depression Scale (HAM-D) — 11.2; 9.7; 11.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- escitalopram (Drug); bupropion (Drug); imipramine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Scale (HAM-D) |
11.2; 9.7; 11.3 | — |
| SECONDARY Clinical Global Impression Scale (CGI) |
2.65; 2.73; 2.67 | — |
Summary
This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.
Eligibility Criteria
Inclusion Criteria
- Ages between 18-65
- Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) 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 (HAMD), 21-item total score >20
- Current (past 6 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
- Non-response to adequate trial of study medication (i.e., > or = 4 weeks on > or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)
- Premenopausal women not using known effective birth control
- Not currently depressed (whether considered due to current treatment or not)
- History of seizure, seizure disorder, anorexia nervosa, or bulimia
- Left-handed -
Data sourced from ClinicalTrials.gov (NCT00404755). 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.