Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

Major depressive disorder (MDD) is a significant public health problem. Existing treatment modalities are not always sufficient to alleviate this disorder. Treatment refractoriness is a common clinical problem. Transcranial direct current stimulation (t-DCS), a non-invasive brain stimulation technique, has been shown to be effective in alleviating depressive symptoms in preliminary studies. There is need to explore the role of t-DCS in Treatment-resistant depression (TRD). Therefore, the investigators aim to undertake this exploratory study. Aim: Compare the role of left prefrontal cortex anodal t-DCS daily stimulation of 4 weeks (20 week days) with sham stimulation in alleviating depressive symptoms in patients with TRD. Methodology: Patients who seek treatment in our treatment resistant depression clinic and who have failed to respond to treatment with two antidepressant medications will be offered to enroll in this study. The aim is to study 20 patients who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD between the ages of 21-65 years. Those subjects that receive sham stimulation will be offered to have active t-DCS stimulation for additional 3 weeks to get any benefit that they may have otherwise missed by being in the sham stimulation group. Results and Conclusions: The investigators will compare the mean baseline and end of treatment Montgomery Asberg depression rating scale between the two groups. The investigators will compare the change in mean depression scores between the baseline and end of treatment in those receiving active t-DCS for a total of 7 weeks duration. This study is innovative and of significance in exploring the role of this novel, easy to administer, safe and cost effective treatment modality.

Key facts

Study ID

NCT02141776

Run by

University of Florida

People needed

3

Starts

2014-05-01

Expected to finish

2018-01-08

Last updated by the study team

2018-01-12

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects that meet criteria for Major depressive disorder (MDD)
• ages 21 to 65 years and
• who are treatment resistant

You may not qualify if…

• Co-morbid substance abuse in last one month.
• Psychotropic medication changes in last two weeks.
• Unstable medical or psychiatric problems that need intensive outpatient or inpatient treatment
• Patients who are not competent to consent for the study
• Urine pregnancy test positive
• Ferromagnetic Implanted devices that use electrical or magnetic currents

Where it is running

• Univ of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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