Trial Outcomes & Findings for Dichotic Listening as a Predictor of Medication Response in Depression (NCT NCT00296725)

Last Updated: 2019-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-05-30

Participant Flow

25 Screened. 4 did not return, 2 withdrew consent. Period 1 started with 17 participants available and eligible to participate in period I were treated with fluoxetine; 2 fluoxetine non-responders, 3 non-remiiters and 3/5 dropouts (n=8) continued to Period 2.

17 participants available and eligible to participate in period I

Participant milestones

Participant milestones
Measure	Fluoxetine / Imipramine 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. 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.
Phase 1: Fluoxetine (1-12 Weeks) STARTED	17
Phase 1: Fluoxetine (1-12 Weeks) COMPLETED	12
Phase 1: Fluoxetine (1-12 Weeks) NOT COMPLETED	5
Phase 2: Imipramine (1-6 Weeks) STARTED	8
Phase 2: Imipramine (1-6 Weeks) COMPLETED	7
Phase 2: Imipramine (1-6 Weeks) NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluoxetine / Imipramine 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. 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.
Phase 1: Fluoxetine (1-12 Weeks) Lost to Follow-up	1
Phase 1: Fluoxetine (1-12 Weeks) Adverse Event	4
Phase 2: Imipramine (1-6 Weeks) Lost to Follow-up	1

Baseline Characteristics

Dichotic Listening as a Predictor of Medication Response in Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine / Imipramine n=25 Participants 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. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Fluoxetine n=17 Participants fluoxetine 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.	Imipramine n=8 Participants imipramine 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.
Hamilton Depression Scale (HAM-D)	10 score on a scale Standard Deviation 7	9 score on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 6 weeks.

Population: Response Rate

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.

Outcome measures

Outcome measures
Measure	Fluoxetine n=17 Participants fluoxetine 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.	Imipramine n=8 Participants imipramine 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.
Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)	7 Participants	4 Participants

Adverse Events

Fluoxetine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Imipramine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluoxetine n=17 participants at risk fluoxetine 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.	Imipramine n=8 participants at risk imipramine 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.
Respiratory, thoracic and mediastinal disorders shortness of breath	5.9% 1/17 • Number of events 1	0.00% 0/8
Psychiatric disorders irritability	5.9% 1/17 • Number of events 1	0.00% 0/8
Immune system disorders rash	11.8% 2/17 • Number of events 2	0.00% 0/8
General disorders lost to follow-up	17.6% 3/17 • Number of events 3	12.5% 1/8 • Number of events 1

Additional Information

Jonathan W. Stewart, M.D., Principle Investigator

New York State Psychiatric Institute

Phone: 646-774-8070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place