Back to results

MARt-Depression Trial

Primary Purpose

Major Depressive Disorder

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Soterix Medical tDCS mini-Clinical Trials system (mini-CT)

Computerized CBT (cCBT)

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring TRD, tDCS, cCBT, Home-based tDCS-cCBT

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of Major Depressive Disorder with most recent episode treated with acute ECT at the Temerty Centre for Therapeutic Brain Intervention, CAMH.
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).
Age 18-85, inclusive.

Exclusion Criteria:

History of a DSM-IV substance use disorder within the past three months
Concomitant major unstable medical illness
Pregnancy or the intention to become pregnant during the study
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)
DSM-IV diagnosis of personality disorder as assessed by a study investigator
Baseline score of < 24 on the MoCA
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)
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)
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
Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus
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
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).
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).

Sites / Locations

Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

tDCS + cCBT

Arm Description

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.

Outcomes

Primary Outcome Measures

Maintained remission of depressive symptoms as measured by the Hamilton Rating Scale for Depression - 24

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03564067

First Posted

June 11, 2018

Last Updated

March 4, 2022

Sponsor

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT03564067

Brief Title

MARt-Depression Trial

Official Title

Maintaining Response With tDCS in Depression (MARt- Depression) Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 5, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

TRD, tDCS, cCBT, Home-based tDCS-cCBT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tDCS + cCBT

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Soterix Medical tDCS mini-Clinical Trials system (mini-CT)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Computerized CBT (cCBT)

Intervention Description

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 Measure Information:

Title

Maintained remission of depressive symptoms as measured by the Hamilton Rating Scale for Depression - 24

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of Major Depressive Disorder with most recent episode treated with acute ECT at the Temerty Centre for Therapeutic Brain Intervention, CAMH. 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). Age 18-85, inclusive. Exclusion Criteria: History of a DSM-IV substance use disorder within the past three months Concomitant major unstable medical illness Pregnancy or the intention to become pregnant during the study 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) DSM-IV diagnosis of personality disorder as assessed by a study investigator Baseline score of < 24 on the MoCA 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) 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) 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 Any dermatological disorder or any cuts/broken skin in the scalp region that may affect the safe delivery of the tDCS stimulus 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 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). 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zafiris J Daskalakis, MD, PhD

Organizational Affiliation

Centre for Addiction and Mental Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Addiction and Mental Health

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6J 1H4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.camh.net/research

Description

Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

Learn more about this trial

MARt-Depression Trial

We'll reach out to this number within 24 hrs