Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT03564067
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2018-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MARt-Depression Trial
Sponsor:
Centre for Addiction and Mental Health
Organization:
Study Overview
Official Title:
Maintaining Response With tDCS in Depression (MARt- Depression) Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.
Detailed Description:
Home-based tDCS-cCBT will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months, in combination with computerized CBT delivered through an online portal for the duration of tDCS each day. Subjects who miss 4 consecutive treatment days or 20 percent of total treatments will be excluded from the study as it is our intention to encourage compliance with the proposed treatments to maintain optimal wellness. All missed treatment days will be recorded in a log for each participant.
Aim 1. To investigate the effectiveness of maintenance tDCS-cCBT for patients with MDD who have responded to a successful acute course of ECT.
Hypothesis 1. tDCS-cCBT will effectively maintain treatment response in MDD in a manner that is non-inferior to that of maintenance ECT.
Aim 1. To investigate the effectiveness of maintenance tDCS-cCBT for patients with MDD who have responded to a successful acute course of ECT.
Hypothesis 1. tDCS-cCBT will effectively maintain treatment response in MDD in a manner that is non-inferior to that of maintenance ECT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: