Electroconvulsive Therapy Amplitude Titration
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|ClinicalTrials.gov Identifier: NCT04621786|
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electroconvulsive Therapy Amplitude Titration for Improved Clinical Outcomes in Late Life Depression|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Experimental arm
All subjects enrolled will receive amplitude titration for their first treatment. The remainder of the ECT series will be completed with traditional (800mA) pulse amplitude with right unilateral electrode placement. This investigation only includes the single open-label arm.
Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface
The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.
- Inventory of Depressive Symptomatology - Clinician (IDS-C) [ Time Frame: The time frame is four weeks (before and after the ECT series). ]The IDS-C is a clinician rating of depression severity. The scoring range is from 0 to 84 with higher scores related to higher depression severity.
- Delis-Kaplan Executive Function System verbal fluency (DKEFS) test score [ Time Frame: The time frame is four weeks (before and after the ECT series). ]The DKEFS-VF is a neuropsychological measure of executive functioning. The scoring range (scaled scores) is between 1 to 19 with higher scores related to superior executive functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621786
|Contact: Christopher Abbott, MDemail@example.com|
|Contact: megan firstname.lastname@example.org|