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Adaptive tDCS for Treatment-Resistant MDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02942368
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Device: tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention 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).
Primary Purpose: Treatment
Official Title: Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS
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.
Device: tDCS
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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults age 18 to 65
  2. History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
  3. Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
  4. Failure of at least 3 prior lifetime antidepressant trials
  5. Good command of the English language

Exclusion Criteria:

  1. Lifetime history of the following, defined by DSM-IV criteria per study physician:

    1. Moderate or severe substance use disorder in the past 6 months with the exception of nicotine use disorder
    2. Dementia or major neurocognitive disorder
    3. Schizophrenia spectrum disorders
    4. Autism spectrum disorder
    5. Depression which has failed to respond to ECT, with treatment failure as determined by evaluating physician
    6. Failure of greater than 6 antidepressant trials in the current depressive episode
  2. Current evidence of the following, defined by present symptomology as per study physician:

    1. Active psychotic symptoms
    2. Bipolar disorder with a current manic, hypomanic, or mixed episode as defined by DSM-IV criteria
    3. Depression secondary to a general medical illness
    4. Dysphoria better explained by a personality disorder
    5. Dysphoria associated with a primary anxiety disorder or PTSD
    6. Active suicidal intention (inability to contract for safety)
    7. Any change in psychotropic medication within 30 days of the initiation of tDCS
    8. History of neurological disorders (e.g., epilepsy) and/or off any treatment medication for a neurological disorder for minimum 3 years (36 months)
    9. Any open wounds (e.g., blisters, burns including sun burns, cuts or irritation) under or near the scalp regions where electrodes are placed
    10. Metal implants (e.g., Deep Brain Stimulator, Vagus Nerve Stimulator)
    11. 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)
    12. Any history of head injury resulting in unconsciousness for more than 5 minutes (e.g., head trauma, brain surgery)
    13. Metallic face or scalp tattoos
    14. Any chronic headaches or migraines (occurring for consecutive days and are longer than an hour)
    15. 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
    16. Any personal history of seizures.
  3. Currently pregnant or lactating, as determined in part from urine pregnancy test at Screening/Baseline appointment and medical history.
  4. Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)

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): NCT02942368


Locations
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United States, Missouri
Washington University in Saint Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Charles Conway, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02942368     History of Changes
Other Study ID Numbers: 6610
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms