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The purpose of the study is to examine the effect of bupropion on seizure threshold and duration in depressed patients receiving right unilateral ultra-brief electroconvulsive therapy (ECT). The investigators plan to recruit 10 patients into the study, administer sustained release (SR) bupropion 4 hours prior to receiving ECT. The investigators plan to compare the seizure threshold and seizure durations between ECT sessions with and without bupropion administration. The study's implication is to examine how ECT can be optimized by rational combination with medications that lower seizure threshold.
Background and significance Depression is the leading cause of disability in individuals aged 15-44, resulting in 400 million disability days in a year (1). The total economic burden of the disease is estimated to be composed of $26.1 billion in direct medical costs, $5.4 billion in suicide-related mortality costs, and $51.5 billion in indirect workplace cost (1). Electroconvulsive therapy (ECT) is the gold-standard treatment for major depressive disorder (MDD) that is severe (2-5). The standard method of ECT used in the US now is right unilateral ultra-brief study. RUL ECT uses a pulse width of \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wellbutrin during ECT 1 | Active Comparator | Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 1 |
|
| Wellbutrin during ECT 2 | Active Comparator | Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellbutrin SR 300Mg Extended-Release Tablet | Drug | Wellbutrin SR 300Mg Extended-Release Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seizure Threshold | 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. | Measured at day 1 and day 2 |
| Change in Seizure Duration | 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. | Measured at day 1 and day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MADRS Score | 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. | Scored on day 1 and day 2 after ECT session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Szabo, MD PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25742202 | Background | Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298. | |
| 16956074 | Background | Beckford-Ball J. An overview of the new NICE guidelines on bipolar disorder. Nurs Times. 2006 Aug 22-28;102(34):23-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Wellbutrin During ECT 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Seizure Threshold | 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. | Posted | Mean | Standard Deviation | millicoulombs | Measured at day 1 and day 2 |
|
Adverse events were assessed on days 1 and 2 of treatment and for a week after treatment 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven T Szabo | DukeUMC | 3524540101 | 3524540101 | steven.szabo@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2017 | May 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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2 Arms of randomization - one wherein patients get Wellbutrin in first ECT and another arm wherein patients get it with second ECT. Counterbalanced randomization
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Blinding to be done - Outcome assessor and care provider will be blinded to randomization arm of subject
| 15820265 | Background | Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004. |
| 9554324 | Background | Frances AJ, Kahn DA, Carpenter D, Docherty JP, Donovan SL. The Expert Consensus Guidelines for treating depression in bipolar disorder. J Clin Psychiatry. 1998;59 Suppl 4:73-9. |
| 23237061 | Background | Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Beaulieu S, Alda M, O'Donovan C, Macqueen G, McIntyre RS, Sharma V, Ravindran A, Young LT, Milev R, Bond DJ, Frey BN, Goldstein BI, Lafer B, Birmaher B, Ha K, Nolen WA, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013. Bipolar Disord. 2013 Feb;15(1):1-44. doi: 10.1111/bdi.12025. Epub 2012 Dec 12. |
| 1771150 | Background | Sackeim HA, Devanand DP, Prudic J. Stimulus intensity, seizure threshold, and seizure duration: impact on the efficacy and safety of electroconvulsive therapy. Psychiatr Clin North Am. 1991 Dec;14(4):803-43. |
| 8872404 | Background | Lisanby SH, Devanand DP, Nobler MS, Prudic J, Mullen L, Sackeim HA. Exceptionally high seizure threshold: ECT device limitations. Convuls Ther. 1996 Sep;12(3):156-64. |
| 26213985 | Background | Tor PC, Bautovich A, Wang MJ, Martin D, Harvey SB, Loo C. A Systematic Review and Meta-Analysis of Brief Versus Ultrabrief Right Unilateral Electroconvulsive Therapy for Depression. J Clin Psychiatry. 2015 Sep;76(9):e1092-8. doi: 10.4088/JCP.14r09145. |
Drug - Wellbutrin SR 300Mg Extended-Release Tablet during ECT session 2.
Wellbutrin SR 300Mg Extended-Release Tablet: Wellbutrin SR 300Mg Extended-Release Tablet
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Seizure Duration | 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. | Posted | Mean | Standard Deviation | seconds | Measured at day 1 and day 2 |
|
|
|
| Secondary | Change in MADRS Score | 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. | Posted | Mean | Standard Deviation | Scored on a scale | Scored on day 1 and day 2 after ECT session |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
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