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MARt-Depression Trial

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ClinicalTrials.gov Identifier: NCT03564067
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health

Brief Summary:
This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Soterix Medical tDCS mini-Clinical Trials system (mini-CT) Behavioral: Computerized CBT (cCBT) Not Applicable

Detailed Description:

Home-based tDCS-cCBT will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months, in combination with computerized CBT delivered through an online portal for the duration of tDCS each day. Subjects who miss 4 consecutive treatment days or 20 percent of total treatments will be excluded from the study as it is our intention to encourage compliance with the proposed treatments to maintain optimal wellness. All missed treatment days will be recorded in a log for each participant.

Aim 1. To investigate the effectiveness of maintenance tDCS-cCBT for patients with MDD who have responded to a successful acute course of ECT.

Hypothesis 1. tDCS-cCBT will effectively maintain treatment response in MDD in a manner that is non-inferior to that of maintenance ECT.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintaining Response With tDCS in Depression (MARt- Depression) Pilot Study
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
tDCS + cCBT
After baseline assessments are complete, participants will be provided with a tDCS device (Soterix Medical tDCS mini-Clinical Trials system (mini-CT)), which is deactivated until a code is provided by the research staff. Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace.
Device: Soterix Medical tDCS mini-Clinical Trials system (mini-CT)
Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). Home-based tDCS will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months.

Behavioral: Computerized CBT (cCBT)
Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace.




Primary Outcome Measures :
  1. Maintained remission of depressive symptoms as measured by the Hamilton Rating Scale for Depression - 24 [ Time Frame: 6 months ]

    Hamilton Rating Scale for Depression (24-item version)

    • This scale is used to quantify the severity of symptoms of depression
    • Scale range: 0-76 (total score)
    • Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
    • Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of Major Depressive Disorder with most recent episode treated with acute ECT at the Temerty Centre for Therapeutic Brain Intervention, CAMH.
  2. Individuals capable to provide consent who are receiving care as outpatients, and are now remitters (defined by the 24-item Hamilton Rating Scale for Depression (HRSD-24) ≤ 10).
  3. Age 18-85, inclusive.

Exclusion Criteria:

  1. History of a DSM-IV substance use disorder within the past three months
  2. Concomitant major unstable medical illness
  3. Pregnancy or the intention to become pregnant during the study
  4. DSM-IV diagnosis of any psychotic disorder, obsessive compulsive disorder, or post-traumatic stress disorder (current or within the last year) as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
  5. DSM-IV diagnosis of personality disorder as assessed by a study investigator
  6. Baseline score of < 24 on the MoCA
  7. Any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, head trauma with loss of consciousness for greater than or equal to five minutes)
  8. Presenting with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, Cushing's disease)
  9. Any intracranial implant (e.g., aneurysm clips, shunts, cochlear implants) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  10. Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus
  11. Requiring a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of ECT
  12. The inability to communicate in spoken and written English fluently enough to complete the neuropsychological tests due to a language barrier or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
  13. Cognitive impairment or physical impairment such that they are unable to learn to, or physically unable to apply tDCS to their scalp without assistance (after training).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564067


Contacts
Contact: Dov Millstone 416-535-8501 ext 36434 Dov.Millstone@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Dov Millstone, MPH    416-535-8501 ext 36434    Dov.Millstone@camh.ca   
Sub-Investigator: Daniel M Blumberger, MD, MSc         
Sub-Investigator: Daphne Voineskos, MD, PhD(c)         
Sub-Investigator: Yuliya Knyahnytska, MD, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Zafiris J Daskalakis, MD, PhD Centre for Addiction and Mental Health

Additional Information:
Responsible Party: Z. J. Daskalakis, Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03564067     History of Changes
Other Study ID Numbers: 126-2016
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Z. J. Daskalakis, Centre for Addiction and Mental Health:
TRD
tDCS
cCBT
Home-based tDCS-cCBT

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders