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

University Medicine Greifswald

Status and phase

Completed

Phase 1

Conditions

Emotions

Treatments

Procedure: Saliva collection

Device: ergoselect II 100/200

Device: VITAPORT

Drug: propranololhydrochloride

Drug: placebo

Device: Net Station® System and compatible Geodesic Sensor Nets®

Device: Mobil-O-Graph® PWA

Device: SpiroScout

Study type

Interventional

Funder types

Other

Identifiers

NCT02509559

BBEmoMem_G

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 - 35 years
male
caucasian
body mass index: > 19 kg/m² and < 27 kg/m²
genotype:
1. being homozygote for ADRB2 haplotype 2 (variant allele) and homozygote for ADRB1 c.1165 (CC)
2. being homozygote for ADRB2 haplotype 2 (variant allele) and homozygote for ADRB1 c.1165 (GG) or heterozygote for ADRB1 c.1165 (CG)
3. being homozygote for ADRB2 haplotype 4 (wild-type) and homozygote for ADRB1 c.1165 (CC)
4. being homozygote for ADRB2 haplotype 4 (wild-type) and homozygote for ADRB1 c.1165 (GG) or heterozygote for ADRB1 c.1165 (CG)
good health as evidenced by the results of the clinical examination, ECG, ergometry and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state; the lower limit for systolic pressure is stated with 110 mm Hg and diastolic blood pressure with 70 mmHg as well as heart frequency should not fall below 50 bpm (WHO definition)
written informed consent

Exclusion criteria

sex: female
hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. bradycardia, hypotonia, av- block I°)
volunteers liable to orthostatic dysregulation, fainting, or blackouts
peripheral circulatory disturbances
gastrointestinal diseases and/or pathological findings (e.g. stenoses), which might interfere with pharmacokinetics and pharmacodynamics of the study medication
obstructive disorder of breathing (e. g. asthma bronchiale)
known allergic reactions to the active ingredients used or to constituents of the study medication
known allergic reactions to any drug therapy in the anamnesis or actual de-allergisation
psoriasis
diabetes mellitus
addiction to hypoglycemia
pheochromocytoma
myasthenia gravis
drug or alcohol dependence
positive drug or alcohol screening
smokers of 10 or more cigarettes per day
positive results in HIV, HBV and HCV screenings
volunteers who are on a diet which could affect the pharmacokinetics of the drug (e. g. vegetarian
heavy tea or coffee drinkers (more than 1L per day)
volunteers suspected or known not to follow instructions of the clinical investigators
volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
less than 14 days after last acute disease
any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors, anticholinergics)
any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-live of the respective drug (except oral contraceptives)
intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication
intake of poppy seed containing food or beverages within 14 days prior to administration of the study medication

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

8 participants in 2 patient groups, including a placebo group

Propanolol

Active Comparator group

Description:

Memory performance for pictures, electrocortical activity, pharmacokinetics, skin-conductance, pulse waves, burdening heart frequency, pulmonary function, α-amylase in saliva, heart rate and blood pressure after administration of one Propranolol-CT 80 mg film-coated tablet.

Treatment: