Major Depressive Disorder Clinical Trial
Official title:
A Randomized Blinded Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation of Left Prefrontal Cortex in Patients With Treatment-resistant Depression
Verified date | January 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | January 8, 2018 |
Est. primary completion date | January 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Subjects that meet criteria for Major depressive disorder (MDD) - ages 21 to 65 years and - who are treatment resistant Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Univ of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery Asberg depression rating scale score | Investigators will measure the changes in Montgomery Asberg depression rating scale scores with trans-cranial direct current stimulation | 6 months |
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