Trial document




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  DRKS00013764

Trial Description

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Title

Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression - A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)

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Trial Acronym

DepressionDC

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URL of the Trial

http://www.gcbs.network/gcbs/projects/clinical-trials/Work-Package-7.html

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00013764
  •   2018/04/13
  •   2015/08/19
  •   yes
  •   Approved
  •   346-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   NCT02530164  (ClinicalTrials.gov)
  •   DEP-1483-0152-I  (Ludwig-Maximilians - University of Munich)
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Health Condition or Problem studied

  •   Major Depressive Disorder
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Active Comparator: real tDCS
    Intervention: Device: Transcranial direct current stimulation (tDCS)
  •   Placebo Comparator: sham tDCS
    Intervention: Device: Transcranial direct current stimulation (tDCS)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- 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 Outcome

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)
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)
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)
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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/30
  •   152
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional 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)

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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.

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Addresses

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    • Ludwig-Maximilians-Universität München
    • Geschwister-Scholl-Platz 1
    • 80539  München
    • Germany
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    • Ms.  Tabea  Nenov-Matt 
    • Germany
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    • Münchner Studienzentrum
    • Ms.  Beate  Schossow 
    • Germany
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    • Klinikum der Universität München, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. MD  Frank  Padberg 
    • Nußbaumstr. 7
    • 80336   München
    • Germany
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    • Klinikum der Universität München, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. MD  Frank  Padberg 
    • Nußbaumstr. 7
    • 80336   München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung; Projektträger DLR
    • Heinrich-Konen-Str. 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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