Trial document
DRKS00008537
Trial Description
Title
Treatment of depression during pregnancy with transcranial direct current stimulation
Trial Acronym
DeSteK
URL of the Trial
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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.
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00008537
- 2015/05/08
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- yes
- Approved
- 47-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
Secondary IDs
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Health Condition or Problem studied
- F32 - Depressive episode
- F33 - Recurrent depressive disorder
- F31.4 - Bipolar affective disorder, current episode severe depression without psychotic symptoms
Interventions/Observational Groups
- acitve tDCS; 2 mA; 2x30 min per day; anode: F3; cathode: F4; total treatments: 20; duration: 14 days.
Characteristics
- Interventional
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- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Treatment
- Single (group)
- N/A
- N/A
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.
Secondary Outcome
With application of the 20th stimulation: Performance of the Comfort Rating Questionnaire (CRQ): proof of a stimulation without side effects.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2015/11/13
- 10
- Monocenter trial
- National
Inclusion Criteria
- Female
- 10 Weeks of pregnancy
- 35 Weeks of pregnancy
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.
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.
Addresses
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start of 1:1-Block address primary-sponsor
- Psychiatrische Klinik
- Mr. Prof. Dr. Frank Padberg
- Nußbaumstr. 7
- 80336 München
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 089/4400-55511
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- padberg at med.uni-muenchen.de
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/forschung/tms/schwerpunkte/tdcs.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Psychiatrische Klinik
- Mr. Prof. Dr. Frank Padberg
- Nußbaumstr. 7
- 80336 München
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 089/4400-55511
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- padberg at med.uni-muenchen.de
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/forschung/tms/schwerpunkte/tdcs.html
end of 1:1-Block address contact scientific-contact -
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- Psychiatrische Klinik
- Ms. Anja Wilkening
- Nußbaumstr. 7
- 80336 München
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 089/4400-55899
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- anja.wilkening at med.uni-muenchen.de
- http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Psychiatrie-und-Psychotherapie/de/forschung/tms/schwerpunkte/tdcs.html
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- ulrich.palm at med.uni-muenchen.de
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end of 1:1-Block address contact materialSupport
Status
- Enrolling by invitation
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Trial Publications, Results and other Documents
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