Trial document





This trial has been registered retrospectively.
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  DRKS00016766

Trial Description

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Title

"North German ElectroConvulsiveTherapy Outcome Register"
Multicentre, prospective observational study on electroconvulsive therapy of psychiatric patients

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Trial Acronym

NEKTOR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Electroconvulsive therapy (ECT) is a proven and effective treatment option for various psychiatric conditions such as severe, therapy-resistant depression.
Although ECT has been used since 1938, its mechanism of action is still not fully understood. Findings from animal experiments indicate that ECT stimulates the release of nerve growth factors, leading to nerve cell growth in certain areas of the brain. In humans, various clinical factors such as Age or psychotic symptoms are known to be predictors for response to ECT. The scientific data on molecular biological risk factors has been growing rapidly in recent years, with no single biomarker identified that could reliably predict a response to ECT so far. Treatment recommendations and disease-influencing factors are mostly based only on small case series. With our study, we want to build a patient registry that opens up the opportunity to explore risk factors and treatment quality of ECT. We also want to measure molecular biological factors such as nerve growth factors and investigate whether they have an influence on the prognosis of the Outcome of the treatment.

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Brief Summary in Scientific Language

The planned study will investigate the influence of clinical and molecular biological factors on the disease and therapy course of patients receiving ECT and to assess the current treatment practice.
The aim of this study is to establish a patient registry with patients receiving ECT and to investigate, in a systematic, prospective approach, insights into the influence of clinical and molecular factors on the disease course of these patients.

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Organizational Data

  •   DRKS00016766
  •   2019/06/27
  •   [---]*
  •   yes
  •   Approved
  •   2842-2015, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   F30-F39 -  Mood [affective] disorders
  •   F20-F29 -  Schizophrenia, schizotypal and delusional disorders
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Interventions/Observational Groups

  •   Patients receiving ECT treatment receive the following examinations:
    Before ECT series: Blood sampling (CRP, TSH, fT3, fT4, TAK, TRAK, MAK, thyroglobulin, DHEA, DHEAS, cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, cortisol, estradiol, progesterone, testosterone, vitamin B12, Folate, vitamin D, homocysteine, NSE, S100, large blood count, HbA1c)

    cMRI
    EEG
    Height / weight / blood pressure / pulse
    DEX suppression test
    Neurological Soft Signs

    Test Psychology:
    SKID II (with interview)
    SCL-90-R
    BDI II
    MADRS
    MMSE
    PANSS
    YMRS

    Before and 15 minutes after the 1st, 4th and last ECT, and 1st and 4th maintenance ECT:
    2EDTA and 2 serum tubes

    After EKT:
    BDI, MADRS, PANSS, YMRS

    After last ECT additionally:
    MMSE
    Height / weight / blood pressure / pulse
    DEX suppression test
    Neurological Soft Signs

    Before 1st and 4th maintenance ECT:
    BDI and MADRS
    MMSE
    Height / weight / blood pressure / pulse
    Neurological Soft Signs
  •   Patients with a major depressive episode with / without psychotic symptoms who are currently receiving no antidepressant medication and no ECT treatment.
    One-time morning blood collection (CRP, TSH, fT3, fT4, TAK, TRAK, MAK, thyroglobulin, DHEA, DHEAS, cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, cortisol, estradiol, progesterone, testosterone, vitamin B12, folate, vitamin D, homocysteine, NSE, S100, large blood count, HbA1c)

    Height / weight / blood pressure / pulse
    DEX suppression test
    Neurological Soft Signs

    Test Psychology:
    SKID II (with interview)
    SCL-90-R
    BDI II
    MADRS
    MMSE
  •   Healthy Controls
    One-time morning blood collection (CRP, TSH, fT3, fT4, TAK, TRAK, MAK, thyroglobulin, DHEA, DHEAS, cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, cortisol, estradiol, progesterone, testosterone, vitamin B12, folate, vitamin D, homocysteine, NSE, S100, large blood count, HbA1c)

    Height / weight / blood pressure / pulse
    DEX-Suppression Test
    Neurological Soft Signs

    Test Psychology:
    SKID II (with interview)
    SCL-90-R
    BDI II
    MADRS
    MMSE
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Remission after 12 ECT treatments
Remission defined as MADRS Score <10 or PANSS-Score <59

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Secondary Outcome

- Time to Response (Response: 50% reduction of the initial value in the self- and external rating scales BDI, MADRS, PANSS); Time to remission (remission: BDI Score <13, MADRS Score <10, PANSS Score <59)
- Analysis of established and new quality standards of treatment (eg postictal suppression index, EEG, frequency and intensity of stimulus, peak heart rate, co-medication, narcosis)
- Recording of adverse effects of treatment (Mini-Mental Status Exam, Adverse Events)
- Molecular biological risk factor analysis focusing on neurotrophic (e.g., BDNF, VEGF, GDNF) and immunological (e.g., TNF-alpha, IL-6, Tpa, S100A10) factors (expression, epigenetic studies) to analyze predictive factors for outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/01
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with ECT treatment (ICD-10 F20.-, F30-F39)
- Patients with major depression who are currently receiving no antidepressant drug treatment, as well as
- healthy control subjects without previous psychiatric illness
- Age ≥ 18 years
- male and female patients
- Treatment in a study center
- Signed informed consent of the patient or his legal guardian

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Exclusion Criteria

- Simultaneous participation in another clinical trial
- Missing consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Stefan  Bleich 
    • Car-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med.  Alexandra  Neyazi 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.med.  Helge  Frieling 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    •   0511-5326571
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    •   [---]*
    •   [---]*
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    • Medizinische Hochschule Hannover
    • Ms.  Hannah  Maier 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Stefan  Bleich 
    • Car-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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