Healthy Volunteers Clinical Trial
Official title:
Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging
Alterations of functional brain networks have been frequently demonstrated in schizophrenia,
although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to
exert its schizophrenia-like effects through modulation of the glutamatergic system, thus
facilitating the investigation of the impact of this specific transmitter system on resting
state functional brain networks. The aim of the study is therefore to use pharmacological
functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved
in schizophrenia in response to ketamine application compared to placebo. 30 healthy
subjects (15 females) will be examined twice using a double-blind, placebo-controlled,
randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated
before, during and after either placebo or ketamine intravenous infusion for 20 minutes.
Prior to the main trial 10 additional participants will be included in an open pilot trial.
Hypothesis: Ketamine application will induce changes in resting state networks previously
associated with schizophrenia and in the connectivity of relevant brain regions such as the
striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of
ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed
before and after ketamine infusion.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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