← Back to Search

tDCS + Mindfulness Meditation for Depression (START Trial)

Toronto, Canada

N/A

Waitlist Available

Led By Daniel Blumberger, MD, MSc

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of Major Depressive Disorder with most recent depressive episode treated with acute rTMS

Age 18-85, inclusive

Must not have

Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus

Requiring a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of tDCS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

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).

See full description

Who is the study for?

This trial is for adults aged 18-85 who have major depressive disorder, responded well to rTMS treatment, and can consent to participate. Excluded are those with unstable illnesses, certain psychiatric disorders like psychosis or PTSD within the last year, significant cognitive impairments, high doses of benzodiazepines or anticonvulsants, recent substance abuse, neurological disorders, or scalp conditions affecting tDCS.Check my eligibility

What is being tested?

The study tests if active tDCS combined with mindfulness meditation helps maintain wellness after rTMS treatment for depression compared to a sham (fake) tDCS. It's a double-blind RCT where neither participants nor researchers know who receives real or sham treatment until the end of the study.See study design

What are the potential side effects?

tDCS may cause mild side effects such as itching, tingling at the electrode sites on the scalp during application; headache; fatigue; nausea; and insomnia. Mindfulness meditation is generally considered safe but may sometimes bring up emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been treated for depression with rTMS.

show original

Select...

I am between 18 and 85 years old.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have skin issues on my scalp that could interfere with treatment.

show original

Select...

I need a strong anxiety medication or seizure medication.

show original

Select...

I do not have any major brain or nerve disorders.

show original

Select...

I have not been diagnosed with a psychotic disorder, OCD, or PTSD in the last year.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

Proportion of responders and remitters who relapse

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active tDCS + mindfulness meditationExperimental Treatment1 Intervention

Participants randomized to this group will receive active tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.

Group II: sham tDCS + mindfulness meditationPlacebo Group1 Intervention

Participants randomized to this group will receive sham tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tDCS + mindfulness meditation

2018

N/A

~70

0 / 6Eligibility criteria met