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Trial Outcomes & Findings for Effect of Bupropion on Seizure Threshold in Depressed Patients (NCT NCT03126682)

NCT ID: NCT03126682

Last Updated: 2019-07-10

Results Overview

Charge in Millicoulombs at which subject gets a seizure with ECT. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Measured at day 1 and day 2

Results posted on

2019-07-10

Participant Flow

Participant milestones

Participant milestones
Measure
Wellbutrin During ECT 1
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Wellbutrin During ECT 2
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Overall Study
STARTED
5
5
Overall Study
COMPLETED
5
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Bupropion on Seizure Threshold in Depressed Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Wellbutrin During ECT 1
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Wellbutrin During ECT 2
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Total
n=10 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
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Continuous
50.2 years
STANDARD_DEVIATION 17.1 • n=5 Participants
45.2 years
STANDARD_DEVIATION 6.5 • n=7 Participants
47.7 years
STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
5 participants
n=7 Participants
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: Measured at day 1 and day 2

Charge in Millicoulombs at which subject gets a seizure with ECT. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.

Outcome measures

Outcome measures
Measure
Wellbutrin During ECT 1
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Wellbutrin During ECT 2
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Change in Seizure Threshold
23.04 millicoulombs
Standard Deviation 5.3
19.68 millicoulombs
Standard Deviation 6

PRIMARY outcome

Timeframe: Measured at day 1 and day 2

Duration of seizures with ECT. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.

Outcome measures

Outcome measures
Measure
Wellbutrin During ECT 1
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Wellbutrin During ECT 2
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Change in Seizure Duration
26.2 seconds
Standard Deviation 14.1
29.6 seconds
Standard Deviation 19.3

SECONDARY outcome

Timeframe: Scored on day 1 and day 2 after ECT session

Scoring of depressive symptoms on the Montgomery Asberg Depression Rating Scale, maximum 60 , minimum 0. Higher scores mean worse outcome. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.

Outcome measures

Outcome measures
Measure
Wellbutrin During ECT 1
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Wellbutrin During ECT 2
n=5 Participants
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
Change in MADRS Score
2.60 Scored on a scale
Standard Deviation 3.2
3.60 Scored on a scale
Standard Deviation 3.4

Adverse Events

Wellbutrin During ECT 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wellbutrin During ECT 2

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

Steven T Szabo

DukeUMC

Phone: 3524540101

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place