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|ClinicalTrials.gov Identifier: NCT03564067|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : March 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Soterix Medical tDCS mini-Clinical Trials system (mini-CT) Behavioral: Computerized CBT (cCBT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintaining Response With tDCS in Depression (MARt- Depression) Pilot Study|
|Actual Study Start Date :||July 5, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
tDCS + cCBT
After baseline assessments are complete, participants will be provided with a tDCS device (Soterix Medical tDCS mini-Clinical Trials system (mini-CT)), which is deactivated until a code is provided by the research staff. Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace.
Device: Soterix Medical tDCS mini-Clinical Trials system (mini-CT)
Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). Home-based tDCS will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months.
Behavioral: Computerized CBT (cCBT)
Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace.
- Maintained remission of depressive symptoms as measured by the Hamilton Rating Scale for Depression - 24 [ Time Frame: 6 months ]
Hamilton Rating Scale for Depression (24-item version)
- This scale is used to quantify the severity of symptoms of depression
- Scale range: 0-76 (total score)
- Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
- Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
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): NCT03564067
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M6J 1H4|
|Principal Investigator:||Zafiris J Daskalakis, MD, PhD||Centre for Addiction and Mental Health|