NESBID: Neuro-Stimulation of the Brain in Depression

Depressive Disorder, Major Clinical Trial

— NESBID  

Official title:

NESBID: Neuro-Stimulation of the Brain in Depression. A Randomized, Controlled Clinical Trial of Transcranial Direct Current Stimulation Augmentation, as Compared to Sham Therapy, in the Treatment of Ultra-resistant Major Depressive Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04159012
• Other study ID #: TDCS2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Electric Stimulation Therapy
• Transcranial Direct Current Stimulation

Intervention

Device:
• Transcranial direct current stimulation
A Sooma transcranial direct current stimulator, using carbon electrodes, a reusable cap (to promote reproducible electrode placement), and disposable sponges that will be soaked in normal saline. The anode will be positioned over the left dorsolateral prefrontal cortex (position F3 on the 10-20 the International EEG system), and the cathode will be positioned over the right dorsolateral prefrontal cortex (position F4).

Locations

Country	Name	City	State
Canada	Grey Nuns Community Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	An observer-assessed score of depression severity. The total is scored from 0 to 60, with higher scores representing greater depression severity	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)	A participant-assessed measurement of depression severity. The total is scored from 0 to 27, with higher scores indicating greater depression severity.	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	Change in the World Health Organization Disability Assessment Schedule score	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	Exploratory language analysis	Change in language characteristics, based on recorded interviews	Baseline and after 6 weeks/trial completion
Secondary	Lexical decision making task	Performance on a task in which patients much distinguish real from fictitious words as quickly as possible	Baseline and after 6 weeks/trial completion
Secondary	tDCS adverse events scale	Adverse events as assessed on a scale derived from a systematic review on side effects that may be associated with tDCS	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	FIBSER	Frequency, Intensity, and Burden of Side-Effects Rating Scale	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	PRISE	Patient-Rated Inventory of Side-Effects Scale	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion
Secondary	YMRS	Young Mania Rating Scale, included to capture treatment-related manic or hypomanic switches	Baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion