Trial Outcomes & Findings for Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study (NCT NCT01748955)
NCT ID: NCT01748955
Last Updated: 2017-11-21
Results Overview
% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task. Task conditions are: Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Measured at Baseline (pre-treatment) and Week 8 (post-treatment)
Results posted on
2017-11-21
Participant Flow
Participant milestones
| Measure |
Bupropion
Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
|
Paroxetine CR
Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
Baseline characteristics by cohort
| Measure |
Bupropion
n=3 Participants
Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
|
Paroxetine CR
n=4 Participants
Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline (pre-treatment) and Week 8 (post-treatment)Population: Major depressive disorder with suicidal thoughts or past suicide attempt.
% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task. Task conditions are: Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents
Outcome measures
| Measure |
Bupropion
n=3 Participants
Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
|
Paroxetine CR
n=4 Participants
Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
|
|---|---|---|
|
Percent Change in Contrast of Parameter Estimates (COPE)
Amygdala Punishment
|
-0.32 Percentage change
Interval -1.53 to 0.93
|
-0.66 Percentage change
Interval -1.22 to -0.13
|
|
Percent Change in Contrast of Parameter Estimates (COPE)
ACC Reward
|
0.29 Percentage change
Interval -1.74 to 2.9
|
-2.12 Percentage change
Interval -7.38 to 0.46
|
|
Percent Change in Contrast of Parameter Estimates (COPE)
ACC Punishment
|
-1.19 Percentage change
Interval -2.15 to -0.3
|
-1.33 Percentage change
Interval -2.49 to -0.86
|
|
Percent Change in Contrast of Parameter Estimates (COPE)
Amygdala Reward
|
-0.90 Percentage change
Interval -2.38 to 0.18
|
-0.87 Percentage change
Interval -1.27 to -0.65
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 8Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts
Outcome measures
| Measure |
Bupropion
n=3 Participants
Participants will receive bupropion XL for 8 weeks.
Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
|
Paroxetine CR
n=4 Participants
Participants will receive Paroxetine CR for 8 weeks.
Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
|
|---|---|---|
|
Change in Suicidal Ideation (SSI Score)
Baseline
|
11 units on a scale
Standard Deviation 4.4
|
4.8 units on a scale
Standard Deviation 3.5
|
|
Change in Suicidal Ideation (SSI Score)
Week 8
|
3.3 units on a scale
Standard Deviation 3.1
|
0.3 units on a scale
Standard Deviation 0.5
|
Adverse Events
Bupropion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paroxetine CR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael F. Grunebaum, MD
New York State Psychiatric Institute
Phone: 6467747573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place