Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

January 31, 2015

Conditions
Emotions
Interventions
DRUG

propranololhydrochloride

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

DRUG

placebo

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

DEVICE

Net Station® System and compatible Geodesic Sensor Nets®

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.

DEVICE

VITAPORT

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.

DEVICE

ergoselect II 100/200

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.

DEVICE

SpiroScout

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.

DEVICE

Mobil-O-Graph® PWA

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.

PROCEDURE

Saliva collection

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

Trial Locations (1)

17487

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT02509559 - Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures | Biotech Hunter | Biotech Hunter