Clinical Investigation: Sooma tDCS in MDD
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Information About this Study
Transcranial direct current stimulation (tDCS) has emerged as an effective, safe and tolerable alternative for the treatment of major depressive disorder (MDD). Its ease of use makes it feasible for self-administration at home, thus offering a neuromodulatory MDD treatment with improved accessibility and cost-utility.
The investigators will enrol 150 eligible patients to the study, and they will be randomized (stratified) in 1:1 ratio to either sham or active tDCS treatment groups. Subject’s eligibility to the study will be determined with the criteria for inclusion and exclusion.
Who Can Participate
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18-65 years of age
Diagnosed with MDD
Score of ≥ 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at study entry
On a stable dose of one antidepressant medication to which they have failed to respond after an adequate course of treatment, with dosage unchanged for at least four weeks prior to study entry
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If during the current MDD episode, more than one antidepressant drug trial has failed, or he/she has been treated with tDCS, TMS or ECT
Having metal implant or broken skin in the stimulation area, having electronic implant, cardiac dysrhythmia, or seizure disorder or being pregnant
Use of antipsychotics and long-acting benzodiazepines
Having neurosurgical history or a diagnosis of psychosis, an addiction disorder (other than nicotine)
Borderline personality disorder, antisocial personality disorder, or neurodegenerative disorder
Why Should I Participate in this Study?
MDD continues to be a serious health issue. In 2020, there has been an estimated 21 million adults in the United States who had at least one major depressive episode.
MDD treatment-related research is an essential component in managing the symptoms of MDD and improving the lives of 20 million people globally.
About the App
This study is being conducted using the Health Storylines™ app which can be accessed through your smartphone, mobile device, laptop, personal computer, tablet, or web browser.
How to Participate
To register your interest in participating, please download the Health Storylines™ app using the links underneath to sign up for this study.
You can also scan the following QR code to access the mobile version.
Thank you for your consideration of this important research study.