Adaptive tDCS for Treatment-Resistant MDD
Primary Purpose
Depressive Disorder, Treatment-Resistant
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 to 65
- History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
- Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
- Failure of at least 3 prior lifetime antidepressant trials
- Good command of the English language
Exclusion Criteria:
Lifetime history of the following, defined by DSM-IV criteria per study physician:
- Moderate or severe substance use disorder in the past 6 months with the exception of nicotine use disorder
- Dementia or major neurocognitive disorder
- Schizophrenia spectrum disorders
- Autism spectrum disorder
- Depression which has failed to respond to ECT, with treatment failure as determined by evaluating physician
- Failure of greater than 6 antidepressant trials in the current depressive episode
Current evidence of the following, defined by present symptomology as per study physician:
- Active psychotic symptoms
- Bipolar disorder with a current manic, hypomanic, or mixed episode as defined by DSM-IV criteria
- Depression secondary to a general medical illness
- Dysphoria better explained by a personality disorder
- Dysphoria associated with a primary anxiety disorder or PTSD
- Active suicidal intention (inability to contract for safety)
- Any change in psychotropic medication within 30 days of the initiation of tDCS
- History of neurological disorders (e.g., epilepsy) and/or off any treatment medication for a neurological disorder for minimum 3 years (36 months)
- Any open wounds (e.g., blisters, burns including sun burns, cuts or irritation) under or near the scalp regions where electrodes are placed
- Metal implants (e.g., Deep Brain Stimulator, Vagus Nerve Stimulator)
- Any skin disorders (e.g., eczema, severe rashes, sensitive skin, any communicable skin disorder or treatment for a communicable skin disorder in the past 12 months) or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- Any history of head injury resulting in unconsciousness for more than 5 minutes (e.g., head trauma, brain surgery)
- Metallic face or scalp tattoos
- Any chronic headaches or migraines (occurring for consecutive days and are longer than an hour)
- If a participant has a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they will also be excluded as per study clinician as we are not aiming to assess the treatment of headache with tDCS
- Any personal history of seizures.
- Currently pregnant or lactating, as determined in part from urine pregnancy test at Screening/Baseline appointment and medical history.
- Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
Sites / Locations
- Washington University in Saint Louis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tDCS
Arm Description
Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Treatments will take place daily, 5 days per week.
Outcomes
Primary Outcome Measures
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT02942368
First Posted
October 21, 2016
Last Updated
July 27, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02942368
Brief Title
Adaptive tDCS for Treatment-Resistant MDD
Official Title
Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment of major depression in several studies, both as a primary and adjunctive treatment. The treatment will be administered under the supervision of a physician with experience in administering the treatment and monitoring for complications. This will be a prospective "adaptive tDCS stimulation" open label research study. Participants will receive 20 minute sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6 weeks. Building on the theory that greater current "dose" may be a significant factor in determining efficacy, this study aims to determine whether higher tDCS current doses lead to greater improvements in depressive symptoms in this population of patients with treatment-resistant major depressive disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Outcomes assessors are blinded and unaware of the specifics of the study (although only a single arm, blinded raters do not know this).
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Experimental
Arm Description
Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Treatments will take place daily, 5 days per week.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.
Primary Outcome Measure Information:
Title
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Time Frame
Measurements at week 0, week 2, week 4, week 5 and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18 to 65
History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
Failure of at least 3 prior lifetime antidepressant trials
Good command of the English language
Exclusion Criteria:
Lifetime history of the following, defined by DSM-IV criteria per study physician:
Moderate or severe substance use disorder in the past 6 months with the exception of nicotine use disorder
Dementia or major neurocognitive disorder
Schizophrenia spectrum disorders
Autism spectrum disorder
Depression which has failed to respond to ECT, with treatment failure as determined by evaluating physician
Failure of greater than 6 antidepressant trials in the current depressive episode
Current evidence of the following, defined by present symptomology as per study physician:
Active psychotic symptoms
Bipolar disorder with a current manic, hypomanic, or mixed episode as defined by DSM-IV criteria
Depression secondary to a general medical illness
Dysphoria better explained by a personality disorder
Dysphoria associated with a primary anxiety disorder or PTSD
Active suicidal intention (inability to contract for safety)
Any change in psychotropic medication within 30 days of the initiation of tDCS
History of neurological disorders (e.g., epilepsy) and/or off any treatment medication for a neurological disorder for minimum 3 years (36 months)
Any open wounds (e.g., blisters, burns including sun burns, cuts or irritation) under or near the scalp regions where electrodes are placed
Metal implants (e.g., Deep Brain Stimulator, Vagus Nerve Stimulator)
Any skin disorders (e.g., eczema, severe rashes, sensitive skin, any communicable skin disorder or treatment for a communicable skin disorder in the past 12 months) or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
Any history of head injury resulting in unconsciousness for more than 5 minutes (e.g., head trauma, brain surgery)
Metallic face or scalp tattoos
Any chronic headaches or migraines (occurring for consecutive days and are longer than an hour)
If a participant has a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they will also be excluded as per study clinician as we are not aiming to assess the treatment of headache with tDCS
Any personal history of seizures.
Currently pregnant or lactating, as determined in part from urine pregnancy test at Screening/Baseline appointment and medical history.
Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Conway, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Adaptive tDCS for Treatment-Resistant MDD
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