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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 June 2023 |
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Main ID: |
NCT02530164 |
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Date of registration:
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19/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression
DepressionDC |
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Scientific title:
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Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC) |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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163 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02530164 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Depression
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Unipolar Depression
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Intervention(s)
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Device: Transcranial direct current stimulation (tDCS)
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Primary Outcome(s)
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Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline.
[Time Frame: 6 weeks]
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Secondary ID(s)
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DEP-1483-0152-I
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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