Adaptive tDCS for Treatment-Resistant MDD



Status:Active, not recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:10/20/2018
Start Date:April 14, 2017
End Date:June 2020

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Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder

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.


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)
We found this trial at
1
site
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
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