Mode
Text Size
Log in / Sign up
N/A Completed N=5 Treatment

Home-based tDCS in Major Depressive Disorder

Source: ClinicalTrials.gov NCT04799405 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MADRS) — 16 units on a scale

Summary

The investigators propose a study of telehealth supervised, caregiver-delivered, home-based transcranial direct current stimulation (tDCS) for antidepressant treatment of patients with an acute depressive episode.

Outcome Measures

OutcomeResultp-value
PRIMARY
Montgomery-Asberg Depression Rating Scale (MADRS)
16
PRIMARY
Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions
1; 0
SECONDARY
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
44.6667
SECONDARY
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)
5.3333
SECONDARY
Beck Depression Inventory (BDI)
10.3333
SECONDARY
Hamilton Depression Rating Scale
7.3333
SECONDARY
Montreal Cognitive Assessment (MoCA)
28.6667
SECONDARY
Digit Span Forward
8
SECONDARY
Digit Span Backward
6

Eligibility Criteria

Patients meeting one of the following criteria may be eligible to participate in this study.

  • Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they cannot access
  • Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they cannot access
  • Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding, but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related regulations or other access concerns
  • Patients with medication-resistant MDD who are referred to rTMS or ECT and are found well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related regulations or other access concerns.

The benefits of this project address a present need due to the COVID-19 pandemic, but also go beyond the present situation and address a larger, pre-existing need. Across all these potential groups of participants, prospective participants will:

  • need to have a primary psychiatrist who agrees to their participation in the study and is willing to continue to follow the patient and work collaboratively with the study team
  • need to be assessed by their primary psychiatrist to be stable enough to be able to remain at home and participate in the present study without undue risk to their safety
  • need to be living with an adult willing and capable to provide oversight and learn to deliver the home-based tDCS
  • have the capability to connect with the study team for daily supervision of the intervention sessions and close safety monitoring, and be willing to commit to doing so

Inclusion Criteria

Individuals with MDD

Participants will be men and women who:

  • Are aged 50 or older
  • Able to read, write, and communicate in English
  • Have a caregiver who is willing and able to provide the home tDCS sessions.
  • Participants must be under the care of a treating psychiatrist who approves of the study participation and believes that TMS or ECT is indicated for his/her patient but that
  • it would not endanger the patient to participate in the present study rather than pursue such alternative, or
  • the patient could not gain access to TMS or ECT due to COVID-19 (The depression phase of bi-polar disorder is not a reason for exclusion if the treating psychiatrist believes TMS or ECT would be indicated).

Participants with MDD must fit into one of the following 3 groups (medication-resistant MDD defined as 1) participant's condition has not responded to prescribed antidepressant medication; 2) participant is medication intolerant, or 3) some other underlying reason):

  • Patients with medication-resistant Major depressive disorder (MDD) who have undergone repetitive transcranial magnetic stimulation (rTMS) or electroconvulsive therapy (ECT) and responded to it but whose benefit has lapsed and they need repeat rTMS or ECT course that they cannot access;
  • Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding, but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related regulations or other access concerns
  • Patients with medication-resistant MDD who are referred to rTMS or ECT and are found well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related regulations or other access concerns.

Further, participants must:

  • Meet criteria for a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) (American Psychiatric Association, 2000), as determined via an tele-health interview with a study psychiatrist, and confirmed with the Mini International Neuropsychiatric Interview (MINI; Version 5.0.0) (Sheehan et al., 1998) and the prospective participant's primary psychiatrist.
  • Currently experiencing a major depressive episode of at least four weeks' duration as part
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04799405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search