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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04159012
Other study ID # TDCS2019
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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