Study Summary
This trial will study whether a combination of transcranial direct current stimulation (tDCS) and mindfulness meditation can help people maintain wellness after an acute course of repetitive transcranial magnetic stimulation (rTMS).
Eligible Conditions
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 6 months
6 months
Proportion of patients maintaining remission of depressive symptoms or response to rTMS treatments as measured by the Hamilton Rating Scale for Depression - 17 Hamilton Rating Scale for Depression (17-item version)
Proportion of responders and remitters who relapse
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
active tDCS + mindfulness meditation
1 of 2
sham tDCS + mindfulness meditation
1 of 2
Experimental Treatment
Non-Treatment Group
200 Total Participants · 2 Treatment Groups
Primary Treatment: active tDCS + mindfulness meditation · Has Placebo Group · N/A
active tDCS + mindfulness meditation
Device
Experimental Group · 1 Intervention: active tDCS + mindfulness meditation · Intervention Types: Devicesham tDCS + mindfulness meditation
Other
ShamComparator Group · 1 Intervention: sham tDCS + mindfulness meditation · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
320 Previous Clinical Trials
75,848 Total Patients Enrolled
78 Trials studying Depression
15,981 Patients Enrolled for Depression
University Health Network, TorontoOTHER
1,380 Previous Clinical Trials
473,239 Total Patients Enrolled
51 Trials studying Depression
11,767 Patients Enrolled for Depression
Daniel Blumberger, MD, MScPrincipal InvestigatorCentre for Addiction and Mental Health
4 Previous Clinical Trials
835 Total Patients Enrolled
4 Trials studying Depression
835 Patients Enrolled for Depression
Eligibility Criteria
Age 18 - 85 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This study aimed to investigate the long-term effectiveness and safety of rTMS in the treatment of major depressive disorder (MDD) with a most recent depressive episode
Individuals who are receiving outpatient care and have responded or remitted (defined as a 50% improvement on any depression scale since the beginning of treatment and an HRSD-17 score of 15 or less, or an HRSD-17 score of 8 or less) are capable of providing consent.
The study population consists of people aged 18 to 85, inclusive.
Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Centre for Addiction and Mental Health | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments