Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures
Condition: Emotions
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the present study is to combine two lines of research, investigating
      the interaction between emotional processing and memory performance (on both behavioral and
      electrophysiological levels) and its modulation by ß-blockade.

      Concerning pharmacological manipulations with ß-blockers, there are no studies, which
      investigated the effects of propranolol on electrophysiological (ERPs) and behavioral
      measures of recognition memory along with their codependence on individual variations of
      adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of
      ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.

      Therefore, the current investigation has been designed to replicate the former results which
      revealed reduced ERP correlates of recognition memory for emotional pictures due to
      administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether
      there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in
      memory performance and/or changes in event-related potentials and in propranolol influences
      on the above mentioned processes.

      In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing
      stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP,
      old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction of
      electrocortical correlates of emotional recognition memory (old-new effect) caused by
      propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the
      emotional information processing and memory formation alone, and on the propranolol
      modulation of those processes.

      Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol such
      as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary function
      and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.
    


Intervention name(s): propranololhydrochloride; placebo; Net Station® System and compatible Geodesic Sensor Nets®; VITAPORT; ergoselect II 100/200; SpiroScout; Mobil-O-Graph® PWA; Saliva collection
Intervention type(s): Drug; Drug; Device; Device; Device; Device; Device; Procedure
Intervention description(s): oral administration of one capsule Propanolol-CT 80 mg Filmtabletten (propranololhydrochloride, film-coated tablet encapsulated, 80 mg, single dose) together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3 with subsequent measuring of propranolol and its clinically relevant metabolites; oral administration of one placebo capsule together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3; Electrocortical activity will be assessed by continuous EEG recording using Net Station® System and compatible Geodesic Sensor Nets® (Electrical Geodesics Incorporated, Eugene, OR, USA), measured at days 1, 3 and 10 of the study. Event related potentials at encoding (late positive potential, LPP) and at retrieval (ERP memory old/new effect) will be computed off-line after acquisition of the data.; Measurement of the skin conductance by VITAPORT (Vitaport EDV Systeme GmbH, Erftstadt, Germany) on study days 1 and 3 at the time points before administration of the study medication, during the psychophysiological measurement and at 4 h. Furthermore, the skin conductance responses will be measured on day 10 during the psychophysiological measurement.; Performance of an ergometry by ergoselect II 100/200 (ergoline GmbH, Bitz, Germany) on study days 1 and 3 at 120 min. The burden will be the same wattage over 4 min, that corresponds to that of reaching 80% of the maximal heart frequency in the prestudy examination.; Performance of a spirometry (SpiroScout, Ganshorn Medizin Electronic GmbH, Niederlauer, Germany) with measuring of the forced expiratory volume in 1 second (FEV1) on study days 1 and 3 before administration of the study medication and at 120 min.; Measurement of pulse waves by Mobil-O-Graph® PWA (I.E.M., Stollberg, Germany) on study days 1 and 3 at the time points -10 min, 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h.; Saliva collection will be performed on study days 1 and 3 at time points -10 min, 80 min, 120 min with subsequent measuring of the concentration of α -amylase
Other intervention name(s): propanolol pharmacokinetics; placebo capsule
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Receptors, Adrenergic; Propranolol