PowerPointPrsentation

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Kompetenznetz Depression Subproject 6.3
Workshop Tutzing, October 2003
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Subproject 6.3 Auditory Evoked Potentials and
123I ADAM-SPECT as Predictors of Differential
Treatment Responses to Serotonergic versus
Noradrenergic Antidepressants O Pogarell1, C
Norra2, G Juckel3, K Tatsch4, U Hegerl1 Depts. of
1Psychiatry and 4Nuclear Medicine, University of
Munich Depts. of Psychiatry, University of
2Aachen and 3Berlin (Charité)
Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...
Original Aim of the Project To investigate the
Loudness Dependence of Auditory Evoked Potentials
(LDAEP) as a predictor of therapeutic responses
to serotonergic or noradrenergic drugs in
patients with major depression.
Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...
Study Design
LDAEP-assessments at baseline unmedicated
depressed patients randomized (11)
to Reboxetine (4 weeks)
Citalopram Treatment evaluation Rating scales
(baseline and follow up)
Workshop Tutzing, October 2003
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Preliminary results (pilot study)
Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• Modifications for 2nd period
• SPECT as additional measure of the serotonergic
  system,
• advanced neurophysiological analyses
• laboratory measures of drug serum concentrations
• new and improved sample size calculations
• inclusion of further study centers

Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...
I. Single Photon Emission Computed Tomography
SPECT

• functional nuclear medicine tool
• radioligands for neuroreceptor studies
• semiquantitative assessment of receptor status

• Serotonintransporter imaging ADAM, ß-CIT

Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...
New techniques of AEP analyses LORETA
Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• II. Laboratory measures
• Assessment of clinical outcomes (and LDAEP,
  SPECT) in relation to drug serum concentration
  levels at week 4
• Adjustment for (SR)-, S-, and R-form
  concentrations

Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• III. Sample size calculations
• based on data and experiences of the pilot study
• taking account of estimated drop out-
• and drug response rates
• alpha 0.05, power 0.84
• ? total recruitment of approx. 140 patients
• ? i.e. 100 patients during 2nd period

Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• IV. Multicenter Study
• Dept. of Psychiatry Dr. C. Norra
• University of Aachen
• Dept. of Psychiatry PD Dr. G. Juckel
• Charité Berlin
• Dept. of Nuclear Medicine Prof. Dr. K. Tatsch
• University of Munich
• University of Linköping Prof. Dr. F. Bengtson

Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• Status Quo
• SPECT-study started, blood samples collected
• Recruitment 97 patients (milestones 110)

Aachen Berlin
Workshop Tutzing, October 2003
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Subproject 6.3, AEP and SPECT as Predictors...

• Future prospects
• Validation of methods
• Confirmation of preliminary data
• Development of screening tools
• - specialized centers
• - automated tools

Workshop Tutzing, October 2003