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tDCS for Major Depressive Disorder (NESBID Trial)

N/A

Waitlist Available

Led By Serdar M Dursun, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)

Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

Awards & highlights

NESBID Trial Summary

This trial will test whether transcranial direct current stimulation is an effective treatment for ultra treatment-resistant depression.

Who is the study for?

This trial is for adults with severe depression who haven't improved after trying at least five different antidepressants, ECT, or ketamine. It's not suitable for pregnant women, those using certain herbal compounds or NMDA-modulating agents, people with psychosis or specific personality disorders, and individuals with electronic implants or certain neurological conditions.Check my eligibility

What is being tested?

The NESBID trial tests if brain stimulation (transcranial direct current stimulation) helps people with ultra treatment-resistant major depressive disorder. Participants will get either real or sham stimulation over several weeks to see if it improves their depression symptoms compared to usual treatments.See study design

What are the potential side effects?

Possible side effects of transcranial direct current stimulation may include discomfort at the electrode sites on the head, itching, tingling sensations during the procedure, headache afterwards, fatigue and in rare cases mood changes.

NESBID Trial Eligibility Criteria

Inclusion Criteria

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

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I am currently experiencing severe depression.

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My depression hasn't improved after trying five different antidepressants, ECT, or ketamine.

NESBID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome measures

Exploratory language analysis

FIBSER

Lexical decision making task

+5 more

NESBID Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active transcranial direct current stimulationExperimental Treatment1 Intervention

Active transcranial direct current stimulation (tDCS), delivered at 2 mA and for 30 minutes, on sequential weekdays, for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy.

Group II: Sham transcranial direct current stimulationPlacebo Group1 Intervention

Sham transcranial direct current stimulation (tDCS), which will ramp up to 2 mA over 17 s, and then ramp down to and remain at 0.3 mA for the remainder of the 30 minute session. The short period of active stimulation is included to stimulate the somatic sensations of active therapy. The trickle current at 0.3 mA is necessary to measure electrode contact and prevent investigators from deducing that the device is no longer active. Participants will receive the sham therapy on sequential weekdays for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation

2012

Completed Phase 3

~650

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,960 Total Patients Enrolled

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,606 Total Patients Enrolled

Serdar M Dursun, MD, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

Transcranial direct current stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04159012 — N/A

Major Depressive Disorder Research Study Groups: Sham transcranial direct current stimulation, Active transcranial direct current stimulation

Major Depressive Disorder Clinical Trial 2023: Transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT04159012 — N/A

Transcranial direct current stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04159012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings in this research project?

"That is correct. According to the info on clinicaltrials.gov, this trial is currently seeking participants and was initially posted in September 2020 with a final update date of May 2022. Sixty individuals are being recruited from one centre for this study."

Answered by AI

How many participants are being accepted into this research project?

"Affirmative. Per the information available on clinicaltrials.gov, this trial is currently recruiting participants. It was posted on September 1st 2020 and amended as of May 26th 2022. Sixty individuals are needed to be recruited across a single site for participation."

Answered by AI