DRKS00013764
Recruiting
未知
Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC) - DepressionDC
udwig-Maximilians-Universität München0 sites152 target enrollmentApril 13, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- udwig-Maximilians-Universität München
- Enrollment
- 152
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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