Trial document




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  DRKS00003134

Trial Description

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Title

Evaluation of striatal dopamine transporter availability in patients with therapyresistent major depression, treated by sleep deprivation and electroconvulsive therapy

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Trial Acronym

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URL of the Trial

http://entfällt

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Brief Summary in Lay Language

Electroconvlusive therapy (ECT) and sleep deprivation (SD) are valuable antidepressive treatments. However, their antidepressive mechanisms are poorly understood. Often its difficult to predict individual efficacy of the treatment or to plan the duration and fequency of ECT course. Here an objective biomarker would be helpful.
The subject of our study is to better understand the changes that ECT and SE might induce in the brain, e.g. transmitter changes. Therefore we plan to investigate the dopamine transporter in the brain by nuclear medicine technique and in the blood. In parallel depressive symptoms and cognitive function of the patients will be evaluated.

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Brief Summary in Scientific Language

Major depression is the most frequent psychiatric disease in adults. Antidepressant drugs in combination with psychotherapy are most commonly used for treatment of major depression. However, a significant fraction of patients (up to 50%) ( , ) turn out to be therapy refractory so that somatic treatment approaches are chosen in accordance with national guidelines. Most notably, these include electroconvulsive therapy (ECT) and sleep deprivation (SD) ( ). Although ECT and SD have been used as very effective treatment in the majority of patients for over 80 years, underlying mechanisms of actions are poorly understood. Against this background, the major aims of the present study are:
- to investigate the effect of SD and ECT on DAT availability in patients with major depression, which will contribute to our understanding of mechanisms of action of SD and ECT,
- to assess in how far possible changes in cerebral DAT expression are associated with the response to ECT and SD in patients with major depression, which may represent an eagerly awaited predictive biomarker of therapeutic effectiveness.

In addition, the present study will contemplate putative laboratory biomarkers (saliva cortisol; blood DAT; DAT, G-protein and ADA polymorphisms) to explore possible interferences of these parameters with ECT and SD response and cerebral DAT availability.

Finally, data from patients with major depression will be compared with data from age- and gender-matched healthy controls to identify possible disease-specific, ECT- and SD- unrelated parameter changes (DAT availability, in particular) and to investigate in how far ECT and SD lead to a normalization thereof.

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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

  •   DRKS00003134
  •   2011/06/15
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  •   yes
  •   Approved
  •   184/11, Ethik-Kommission der Albert-Ludwig-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
  •   F33.3 -  Recurrent depressive disorder, current episode severe with psychotic symptoms
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Interventions/Observational Groups

  •   sleep deprivation one night, after a break of 7 days electroconvulsive therapy starts for a course of 6 weeks, 2 times weekly; treatment in patient with major depression
  •   healthy controls without intervention
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
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Primary Outcome

Comparison of striatal DAT availability in patients with major depression at baseline, after one night of total SD and after 6 weeks of ECT assessed with [123I]FP-CIT SPECT

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Secondary Outcome


- comparison of DAT availability in major depression with DAT availability of healthy controls at baseline, after one night of total SD and after 6 weeks of ECT with [123I]FP-CIT-SPECT

- correlation of DAT availability in major depression and healthy controls with DAT availability of lymphcytes at baseline, after one night of total SD and after 6 weeks of ECTby semiquantitative PCR from blood samples

- comparison of clinical parameters. psychiatric examination (especially affectivity and cognitive function) in patients at baseline, after one night of total SD and after 6 weeks of ECTby standardized clincial tests
(HMD; BDI; congitive test battery).

- correlation of clinical parameters with striatal and lymphocatic DATavailability in major depression at baseline, after one night of total SD and after 6 weeks of ECT

-correlation of biomarkers (polymorphisms of DAT-gen, of adenosindesaminase-gen by PCR from blood samples, saliva cortisol) with striatal und lymphcytic DAT-availability

-correlation of clinical parameters with above mentioned biomarkers.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/12/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

a) written informed consent
b) age 18 to 80 years
c) patients: diagnosis of major depression according to ICD10 criteria AND refractory to at least two preceding evidence-based therapies, scheduled for SD and ECT
d) cerebral MRI without structural changes possibly responsible for an affective disorder

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Exclusion Criteria

e) pregnancy (excluded by pregnancy test in fertile women) and lactation
f) comorbidity of another psychiatric disease (axis I disorder or substance abuse within last 6 months in patients resp. ever in controls)
g) intake of drugs or substances inferring with DAT binding (e.g. mazindol, bupropione, radafaxine, amphetamine, methamphetamine, methylphenidate, cocaine, etc.)
h) conditions that may preclude proper SPECT acquisition (e.g., severe claustrophobia, back pain, etc.)
i) previous participation in nuclear medicine trials
j) participation in medical trails within the last 6 months
k) symptomatic affective disorder (e.g, due to a structural brain lesion on MRI)
l) severe neurological disease, in particular those affecting nigrostriatal integrity (e.g., dementia, neurodegenerative Parkinson syndrome, restless legs syndrome, epilepsy, cerebrovascular disease)
m) any malignant disease with possible impact on life expectancy
n) severe cardiovascular disease e.g. Angina, chronic heart failure, arrhythmia)
o) any severe internal disease with possible impact on life expectancy (e.g., CAD, uncontrolled hypertension, liver or kidney disease, etc.)
p) known allergic reaction on perchlorate, relevant thyroid disease (e.g., thyroid cancer; preoperative need to block thyroid with iodine), relevant abnormal blood counts, earlier blood count changes due to perchlorate.
q) acute suicidal tendencies
r)difficulties to give informend consent

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Addresses

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    • Universitätsklinik Freiburg
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Dr.  Sabine  Hellwig 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Dr.  Sabine  Hellwig 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universität Freiburg, Abteilung Psychiatrie und Psychotherapie
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.