NESBID: Neuro-Stimulation of the Brain in Depression

Not Applicable

Active, not recruiting

• Conditions: Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Transcranial Direct Current Stimulation; Electric Stimulation Therapy
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT04159012
• Lead Sponsor: University of Alberta

Brief Summary

In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients.

In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment.

The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2020-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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)

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Exclusion Criteria

• Have been diagnosed with psychosis, an addiction disorder (other than nicotine), borderline personality disorder, or antisocial personality disorder, as these conditions could interfere with adherence to the study protocol
• Are currently using a herbal compound or known NMDA-modulating agent, as these substances could interfere with the induction of LTP and thereby limit the effectiveness of tDCS
• Are pregnant, as tDCS has not been adequately studied in this population
• Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active transcranial direct current stimulation	Transcranial direct current stimulation	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.
Sham transcranial direct current stimulation	Transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	An observer-assessed score of depression severity. The total is scored from 0 to 60, with higher scores representing greater depression severity

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	A participant-assessed measurement of depression severity. The total is scored from 0 to 27, with higher scores indicating greater depression severity.
FIBSER	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	Frequency, Intensity, and Burden of Side-Effects Rating Scale
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	Change in the World Health Organization Disability Assessment Schedule score
tDCS adverse events scale	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	Adverse events as assessed on a scale derived from a systematic review on side effects that may be associated with tDCS
PRISE	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	Patient-Rated Inventory of Side-Effects Scale
YMRS	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion	Young Mania Rating Scale, included to capture treatment-related manic or hypomanic switches
Lexical decision making task	Baseline and after 6 weeks/trial completion	Performance on a task in which patients much distinguish real from fictitious words as quickly as possible
Exploratory language analysis	Baseline and after 6 weeks/trial completion	Change in language characteristics, based on recorded interviews

Trial Locations

Locations (1)

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada