Trial Outcomes & Findings for Dichotic Listening as a Predictor of Medication Response in Depression (NCT NCT00404755)
NCT ID: NCT00404755
Last Updated: 2018-04-30
Results Overview
Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
6 weeks or last visit in Phase
Results posted on
2018-04-30
Participant Flow
Recruitment Period: 7/24/2006 - 4/7/2008 Recruitment Location: outpatient research clinic
Patients had to have not taken psychotropic medication for at least two weeks (no fluoxetine for at least 5 weeks) and had to produce a urine negative for commonly abused substances. Current use of psychotropic medication or a positive urine toxicology screen would abort further study participation.
Participant milestones
| Measure |
Bupropion
this was the initial treatment given to all patients except one who was ineligible for bupropion and received escitalopram
bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
|---|---|
|
Phase I (Bupropion)
STARTED
|
17
|
|
Phase I (Bupropion)
COMPLETED
|
13
|
|
Phase I (Bupropion)
NOT COMPLETED
|
4
|
|
Phase II (Escitalopram)
STARTED
|
11
|
|
Phase II (Escitalopram)
COMPLETED
|
9
|
|
Phase II (Escitalopram)
NOT COMPLETED
|
2
|
|
Phase III (Imipramine)
STARTED
|
3
|
|
Phase III (Imipramine)
COMPLETED
|
3
|
|
Phase III (Imipramine)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Bupropion
this was the initial treatment given to all patients except one who was ineligible for bupropion and received escitalopram
bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
|---|---|
|
Phase I (Bupropion)
Adverse Event
|
3
|
|
Phase I (Bupropion)
Other
|
1
|
|
Phase II (Escitalopram)
Lost to Follow-up
|
2
|
Baseline Characteristics
Dichotic Listening as a Predictor of Medication Response in Depression
Baseline characteristics by cohort
| Measure |
Bupropion
n=17 Participants
bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 weeks or last visit in PhasePopulation: Participants were included if they were given that medication
Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.
Outcome measures
| Measure |
Bupropion
n=17 Participants
bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
Escitalopram
n=10 Participants
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
|
Imipramine
n=3 Participants
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
|
|---|---|---|---|
|
Hamilton Depression Scale (HAM-D)
|
11.2 units on a scale
Standard Deviation 7.9
|
9.7 units on a scale
Standard Deviation 6.4
|
11.3 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 6 weeks or last visit in PhaseThe CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse).
Outcome measures
| Measure |
Bupropion
n=17 Participants
bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
Escitalopram
n=11 Participants
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
|
Imipramine
n=3 Participants
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
|
|---|---|---|---|
|
Clinical Global Impression Scale (CGI)
|
2.65 units on a scale
Standard Deviation 1.12
|
2.73 units on a scale
Standard Deviation 1.10
|
2.67 units on a scale
Standard Deviation 0.58
|
Adverse Events
Escitalopram
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Bupropion
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Imipramine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escitalopram
n=11 participants at risk
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
|
Bupropion
n=17 participants at risk
bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
Imipramine
n=3 participants at risk
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
|
|---|---|---|---|
|
Immune system disorders
allergic reaction
|
0.00%
0/11 • 6 weeks
6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
Other adverse events
| Measure |
Escitalopram
n=11 participants at risk
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
|
Bupropion
n=17 participants at risk
bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
|
Imipramine
n=3 participants at risk
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 3 • 6 weeks
6 weeks
|
0.00%
0/17 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
Reproductive system and breast disorders
anorgasmia
|
45.5%
5/11 • Number of events 5 • 6 weeks
6 weeks
|
0.00%
0/17 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
General disorders
headache
|
9.1%
1/11 • Number of events 1 • 6 weeks
6 weeks
|
17.6%
3/17 • Number of events 3 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
General disorders
overstimulatioin
|
0.00%
0/11 • 6 weeks
6 weeks
|
11.8%
2/17 • Number of events 2 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
General disorders
insomnia
|
9.1%
1/11 • Number of events 1 • 6 weeks
6 weeks
|
17.6%
3/17 • Number of events 3 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
Immune system disorders
allergic reaction
|
0.00%
0/11 • 6 weeks
6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
6 weeks
|
0.00%
0/3 • 6 weeks
6 weeks
|
|
Gastrointestinal disorders
dry mouth
|
9.1%
1/11 • Number of events 1 • 6 weeks
6 weeks
|
0.00%
0/17 • 6 weeks
6 weeks
|
100.0%
3/3 • Number of events 3 • 6 weeks
6 weeks
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/11 • 6 weeks
6 weeks
|
11.8%
2/17 • Number of events 2 • 6 weeks
6 weeks
|
66.7%
2/3 • Number of events 2 • 6 weeks
6 weeks
|
|
General disorders
a.m. grogginess
|
0.00%
0/11 • 6 weeks
6 weeks
|
0.00%
0/17 • 6 weeks
6 weeks
|
33.3%
1/3 • Number of events 1 • 6 weeks
6 weeks
|
|
Cardiac disorders
orthostatic hypotension
|
0.00%
0/11 • 6 weeks
6 weeks
|
0.00%
0/17 • 6 weeks
6 weeks
|
33.3%
1/3 • Number of events 1 • 6 weeks
6 weeks
|
Additional Information
Jonathan W. Stewart, M.D.
New York State Psychiatric Institute
Phone: 646-774-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place