Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)
- Conditions
- Major Depressive DisorderF33Recurrent depressive disorder
- Registration Number
- DRKS00013764
- Lead Sponsor
- udwig-Maximilians-Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 152
Men and women 18-65 years of age.
- Primary DSM-5 diagnosis of Major Depression as assessed by the Structured Clinical Interview for DSM-5 Axis I Disorders, Research Version (SCID-5-RV) with a single or recurrent episode with the additional requirements of a current episode with a duration of =4 weeks.
- Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of =2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
- Total HDRS-21 =15 at the screening visit.
- The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 2 on the ATHF) in the current episode.
- Patient is taking a SSRI of adequate dose and =4 weeks (defined as a minimum level of 2 on the ATHF) in the current episode.
- Capable and willing to provide informed consent.
- Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e <. 2 years post-menopausal)
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
- Acute risk for suicide (MADRS, item 10 score of >4 or as assessed by the C-SSRS, agree to item 4 and/or to item 5).
- High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode (each attempt with an ATHF score of >3).
- Treatment with electroconvulsive therapy in the present episode.
- Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
- Any other relevant psychiatric axis-I- and/or axis-II-disorder.
- Any relevant instable medical condition.
- History of treatment with tDCS for any disorder.
- Pregnancy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline.; time frame: 6 weeks<br>
- Secondary Outcome Measures
Name Time Method 1. clinically relevant therapeutic effect (min. 50% improvement in MADRS scores between baseline and post treatment assessments) and Remission (MADRS-score of 10 or less in follow-up; questionnaires)<br>2. Change of symptom severity in depression (Beck-Depression-Inventory II, Clinical Global Impression Scale and Global Assessment of Functioning at the end of therapy and in follow-up compared to baseline assessment; questionnaires)<br>3. Change in social functioning and health Status (Short Form 36 at the end of therapy and in follow-up compared to baseline assessment; questionnaire)<br>4. Change in anhedonia and anxiety (Snaith-Hamilton-Pleasure-Scale, State-Trait-Anxiety-Inventory at the end of therapy and in follow-up compared to baseline assessment; questionnaires)