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NESBID: Neuro-Stimulation of the Brain in Depression (NESBID)

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ClinicalTrials.gov Identifier: NCT04159012
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 9, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) [ Time Frame: 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.
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 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
  • Exploratory language analysis [ Time Frame: Baseline and after 6 weeks/trial completion ]
    Change in language characteristics, based on recorded interviews
  • Lexical decision making task [ Time Frame: Baseline and after 6 weeks/trial completion ]
    Performance on a task in which patients much distinguish real from fictitious words as quickly as possible
  • tDCS adverse events scale [ Time Frame: 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
  • FIBSER [ Time Frame: 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
  • PRISE [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NESBID: Neuro-Stimulation of the Brain in Depression
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder, Major
  • Depressive Disorder, Treatment-Resistant
  • Transcranial Direct Current Stimulation
  • Electric Stimulation Therapy
Intervention  ICMJE 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).

Other Name: Sooma tDCS
Study Arms  ICMJE
  • Experimental: Active 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.
    Intervention: Device: Transcranial direct current stimulation
  • Sham Comparator: Sham 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.
    Intervention: Device: Transcranial direct current stimulation
Publications * Suleman R, Tucker BV, Dursun SM, Demas ML. The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. JMIR Res Protoc. 2021 Mar 17;10(3):e22805. doi: 10.2196/22805.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael L Demas, MD 7807357292 mdemas@ualberta.ca
Contact: Raheem Suleman, MD rsuleman@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159012
Other Study ID Numbers  ICMJE TDCS2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Alberta Health Services
Investigators  ICMJE
Principal Investigator: Serdar M Dursun, MD, PhD University of Alberta
PRS Account University of Alberta
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP