Adaptive tDCS for Treatment-Resistant MDD (NCT02942368) | Clinical Trial Compass
TerminatedPhase 1
Adaptive tDCS for Treatment-Resistant MDD
Stopped: We did not have staff to run this project any longer
United States5 participantsStarted 2017-04-14
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Improvement in depressive symptoms as measured by mean change in the Montgomery-Ã…sberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Timeframe: Measurements at week 0, week 2, week 4, week 5 and week 6