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Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression (DepressionDC)

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ClinicalTrials.gov Identifier: NCT02530164
Recruitment Status : Unknown
Verified January 2016 by Daniel Keeser, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : August 20, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Keeser, Ludwig-Maximilians - University of Munich

Brief Summary:

Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; an estimated 20-40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. A 15-25% of patients manifest a chronic, treatment-resistant course of illness, resulting in a need for additional treatment options. Brain stimulation techniques are considered as a promising therapeutic approach in affective disorders like MDD. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. In the largest 2x2 factorial randomized controlled trial in MDD to date, Brunoni et al. (2013) have shown that tDCS combined with an Selective Serotonin Reuptake Inhibitor (SSRI; sertraline) resulted in an antidepressant efficacy superior to placebo treatment, tDCS alone and sertraline alone.

The purpose of this study is to explore the sustained efficacy and tolerability of repeated tDCS for the treatment of MDD. It is hypothesized that prefrontal tDCS in combination with an SSRI will provoke an antidepressant effect while antidepressant medication alone (sham tDCS) did not. This will be measured by the change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores after 6 weeks of treatment.

In this randomized, placebo-controlled multicenter trial (5 centers involved) patients with a diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS (anode over electrode position F3, cathode over F4, 5 sessions/week for 4 weeks followed by 2 sessions/week for 2 weeks, 24 treatments in sum, 30min/day, 2mA intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation), as adjunctive treatment with a SSRI. Follow-up per patient is 3 and 6 months after the last tDCS treatment session. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of the individual symptomatology.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial direct current stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: real tDCS Device: Transcranial direct current stimulation (tDCS)
active/sham tDCS as adjunctive treatment with a SSRI

Placebo Comparator: sham tDCS Device: Transcranial direct current stimulation (tDCS)
active/sham tDCS as adjunctive treatment with a SSRI




Primary Outcome Measures :
  1. Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530164


Contacts
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Contact: Principal Investigator (LKP) Frank Padberg, Prof. MD frank.padberg@med.uni-muenchen.de
Contact: Jana Nolden, Dipl.-Psych. psy-ddc@med.uni-muenchen.de

Locations
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Germany
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich Recruiting
Munich, Germany, 80336
Contact: Frank Padberg, Prof, MD, PhD, PD    49-89-5160-5879    frank.padberg@med.uni-muenchen.de   
Contact: Daniel Keeser, MSc    49-89-153-314    daniel.keeser@med.uni-muenchen.de   
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich

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Responsible Party: Daniel Keeser, Dr. Dipl.-Psych., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02530164     History of Changes
Other Study ID Numbers: DEP-1483-0152-I
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Daniel Keeser, Ludwig-Maximilians - University of Munich:
tDCS
SSRI

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders