Trial document





This trial has been registered retrospectively.
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  DRKS00019092

Trial Description

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Title

Social cognition following deep brain stimulation of the medial forebrain bundle in treatment-resistant depression

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Deep Brain Stimulation is currently under investigation for treatment-resistant depression. Early improvements in social cognition and functioning have been shown after the treatment with deep brain stimulation. In those previous studies, social cognition has been measured via self-rating questionnaires. Until today, studies are lacking that investigate changes of social cognition after the treatment with deep brain stimulation in treatment-resistant depression with computer-based behavioral tasks.
In the current study, social cognition will be measured using two tasks as well as self-rating questionnaires investigating basal as well as complex factors of social cognition (emotion recognition as well as empathy and theory of mind). Other studies reported changes in those abilities after different kinds of antidepressant treatment. Long-term efficacy of antidepressant treatment could be predicted by early improved emotion recognition. Dysfunctions in empathy and theory of mind have been rarely studied in treatment-resistant depression and results are lacking. The current study has the goal to study differences between patients with treatment-resistant depression and healthy controls comparing basal and complex social cognition abilities. Furthermore changes in basal and complex social cognition abilities are followed up with antidepressant effects of deep brain stimulation and status of stimulation.

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Organizational Data

  •   DRKS00019092
  •   2019/11/13
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  •   yes
  •   Approved
  •   579/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   Patients with treatment-resistant depression who participate in the FORESEE III study and are treated with deep brain stimulation of the medial forebrain bundle are going to be parallely included in this study if they agree separately. Patients are informed and need to consent in the study at baseline (preoperative). In total, there is one time point before and six time points after the implantation of the deep brain stimulation system. At these dates, patients have to answer three questionnaires as well as one to two computer-based tests. The appointment is planned for 60 to 90 minutes per patient.
  •   Healthy controls; participants in this arm are going to be measured once. Participants are informed and have to consent in this study. Then, everything is conducted parallely to the visit of the patients. The appointment is planned for 120 minutes per participant.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Emotion recognition (EmoDetect) and Theory of Mind (ToM) ability (EmpaToM) at baseline, comparision of patients with treatment-resistant depression and healthy controls.

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Secondary Outcome

Change of emotion recognition and Theory of Mind ability after four months of treatment with active stimulation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/09/06
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   75   Years
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Additional Inclusion Criteria

Inclusion criteria for patients with treatment-resistant depression are described in the main study investigating the efficacy of deep brain stimulation in treatment-resistant depression (registered at clinicaltrials.gov). For healthy controls, no inclusion criteria are defined. Healthy controls are matched.

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Exclusion Criteria

Exclusion criteria for patients with treatment-resistant depression are described in the main study investigating the efficacy of deep brain stimulation in treatment-resistant depression (registered at clinicaltrials.gov). For healthy controls, no exclusion criteria are defined. Healthy controls are matched.

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Addresses

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    • Department für Psychische ErkrankungenKlinik für Psychiatrie und PsychotherapieUniklinik FreiburgAbteilung für Interventionelle Biologische Psychiatrie
    • Mr.  Prof. Dr.  Thomas E  Schläpfer 
    • Hauptstraße 5
    • 79104  Freiburg i. Breisgau
    • Germany
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    •   0761 270 69800
    •   0761 270 9669800
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    • Department für Psychische ErkrankungenKlinik für Psychiatrie und PsychotherapieUniklinik FreiburgAbteilung für Interventionelle Biologische Psychiatrie
    • Ms.  Hannah  Kilian 
    • Hauptstraße 5
    • 79104  Freiburg i. Breisgau
    • Germany
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    • Department für Psychische ErkrankungenKlinik für Psychiatrie und PsychotherapieUniklinik FreiburgAbteilung für Interventionelle Biologische Psychiatrie
    • Ms.  Hannah  Kilian 
    • Hauptstraße 5
    • 79104  Freiburg i. Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Department für Psychische ErkrankungenKlinik für Psychiatrie und PsychotherapieUniklinik FreiburgAbteilung für Interventionelle Biologische Psychiatrie
    • Mr.  Prof. Dr.  Thomas E  Schläpfer 
    • Hauptstraße 5
    • 79104  Freiburg i. Breisgau
    • Germany
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    •   0761 270 69800
    •   0761 270 9669800
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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