Trial document

drksid header


Trial Description

start of 1:1-Block title


Treatment of depression during pregnancy with transcranial direct current stimulation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Depressive disorders during pregnancy are risk factors for child and mother and are currently treated with antidpressant medication. However there is a risk of teratogeneity and malformations under antidepressant treatment. Transcranial direct current stimulation is a tool for modulating neuronal activity in the brain and provides antidepressant efficacy. Systemic side effects for child and mother are not likely due to the focality of the stimulation to the brain. In this study depressed pregnant women are treated with twice-daily stimulation for two weeks. Antidepressant medication will not be given.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

transcranial direct current stimulation (tDCS) is a non-invasive tool for the modulation of neuronal activity and shwos antidepressant efficacy when applied to the prefrontal cortex. Several syfety studies showed that tDCS has no systemic side effects. For this reason, application for depression in pregnancy is possible and reasonable. In this study, depressed pregenant women reluctant to pharmacological treatment will be given a series of 2 mA/30 min tDCS (F3/F4) twice daily for two weeks.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?


end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:


end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008537
  •   2015/05/08
  •   [---]*
  •   yes
  •   Approved
  •   47-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F31.4 -  Bipolar affective disorder, current episode severe depression without psychotic symptoms
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   acitve tDCS; 2 mA; 2x30 min per day; anode: F3; cathode: F4; total treatments: 20; duration: 14 days.
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

With application of the 20th stimulation: performance of rating instuments: Hamilton Depression Rating Scale-21; Beck Depression Inventory; WHO-Qualitiy of Life Bref; CGI; GAF; Trail Making Test A/B.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

With application of the 20th stimulation: Performance of the Comfort Rating Questionnaire (CRQ): proof of a stimulation without side effects.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2015/11/13
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   10   Weeks of pregnancy
  •   35   Weeks of pregnancy
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

current pregnancy; Age 18-45; diagnosis of a depressive syndrome without etiologic conclusion; HAMD score minimum 15; normal gynecologic-obstetric and fetal examination; ability to give informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

lack of informed consent; other severe psychiatric disorders; suicidality; Treatment with psychopharmacologic drugs; brain or skull trauma in anamnesis; structural brain damage; Epilepsy; electronic implants in skull or neck; malignant diseases; severe skin or infectious diseases; heart or lung diseases; fetal malformations; pregnancy at risk.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Ludwig-Maximilians-Universität München, Klinik für Psychiatrie
    • Mr.  Dr.  Ulrich  Palm 
    • Nussbaumstr. 7
    • 80336  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Enrolling by invitation
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.