LVR-Klinikum Düsseldorf Hospital of the Heinrich-Heine University ...

s D. Durstewitz, Centre for Theoretical and
Computational Neuroscience, University of Plymouth,
UK
s D. R. Weinberger, Genes, Cognition & Psychosis
Program, National Institute of Mental Health, National
Institutes of Health, USA
s R. W. Cox, Analysis of Functional NeuroImages (AFNI),
National Institute of Mental Health, National Institutes
of Health, USA
s R. Coppola, MEG Priority Facility, National Institute of
Mental Health, National Institutes of Health, USA
In addition, there are close contacts with several other
groups within the context of the DFG priority programme
1226 “Nicotine”.
Projects
Double-blind dose-titration study for investigating the
security, tolerance and pharmacokinetics of multi-doses
of the test substance JNJ-x administered once and twice a
day to male and female patients with stable schizophrenia
Participation in the homonymous multi-centre study at the
request of FOCUS Clinical Drug Development und Janssen-
Cilag International
F. Musso, W. Friedrich, G. Winterer in cooperation with the
study service centre of the LVR-Klinikum
Project period: 2008
Financing: FOCUS Clinical Drug Development and
Janssen-Cilag International
In this multicentre phase II trial (with a total of 5 study
centres) the study drug JNJ-x…, which has not yet been
approved, was tested for the first time in male and female
patients with schizophrenia. The main objective of this study
was to investigate the safety and tolerability of JNJ-x… with
increasing dosages (dose titration), the pharmacokinetic
profile in patients’ plasma of JNJ-x… administered once or
twice a day and the effect of JNJ-x… on the plasma prolactin
level. In addition to the 6 planned patients, the NPRL also
included 5 additional patients in the study.
ReseaRch
Multi-centre randomised, double-blind,
placebo-controlled, parallel group, dose effect
study to assess the effectiveness and security of
OROS methylphenidate retard in adults with attention
deficit syndrome (“Lambda2”)
Participation in the homonymous multi-centre study of
Janssen-Cilag International
G. Winterer, S. Botterweck, R. Schwark
Project period: 2008–2009
Financing: Janssen-Cilag International
The aim of the study was to investigate the efficacy
and safety of two different doses (54 and 72 mg/day) of
OROS Methylphenidate Retard in adults with ADHS in
comparison with a placebo treatment. The study assessed
the degree of severity before, during and after a treatment
period of 13 weeks by using observer and self-rating
procedures for ADHS in adults (CAARS) and various other
psychopathological measures of comorbidity (particularly
depression, anxiety and dependence behaviour), and also
assessed the effects of treatment on social and vocational
measures and physiological parameters (to evaluate basic
safety criteria). Between October and November 2008
(start of data collection to the end of the stated recruitment
period), the Düsseldorf test centre included a total of eight
patients in the study.
Attention network, nicotine addiction and
alpha4beta2-nAch receptor genotype in healthy
subjects and patients with schizophrenia
G. Winterer, A. Mobascher, T. Warbrick, J. Brinkmeyer,
F. Musso in cooperation with the Institute for Neuroscience
and Medicine, Jülich Research Centre (G. Fink, J. Shah)
Project period: 2007–2009
Financing: DFG funding Wi 1316/7-1
In this pharmaco-imaging study, healthy smokers and nonsmokers
from the above mentioned multi-centre study are
being investigated, as well as smokers and non-smokers
suffering from schizophrenia. The aim is to evaluate the
influence of nicotine on attention processes in subjects
without mental disorders and in patients with schizophrenia
in relation to smoking status. In addition, genetic influences
are being investigated. The study is a double-blind, placebocontrolled
study with a cross-over design, i.e. subjects take
nicotine and placebo in randomised order, before performing
tasks that require attention. Brain activity is studied using
EEG and fMRT simultaneously. On the following day,
the conditions (nicotine and placebo) are repeated when
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