NCT02509559: BBEmoMem_G

Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures After Single Dose (80 mg) Administration and Relationships Between ß1- and ß2-adrenoreceptors Genotype and Both the Information Processing and the Propranolol Effects in 64 Healthy Male Subjects

Completed Phase 1 Last updated 23 July 2015

What this trial tests

Phase 1 trial testing propranololhydrochloride in Emotions in 8 participants. Completed in 1 January 2015.

Timeline

1 October 2013

Primary endpoint
1 February 2014

1 January 2015

Quick facts

Lead sponsor	University Medicine Greifswald
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	8
Start date	1 October 2013
Primary completion	1 February 2014
Estimated completion	1 January 2015
Sites	1 location across Germany

Drugs / interventions tested

• propranololhydrochloride — full drug profile →
• placebo
• Net Station® System and compatible Geodesic Sensor Nets®
• VITAPORT
• ergoselect II 100/200
• SpiroScout
• Mobil-O-Graph® PWA
• Saliva collection — full drug profile →

Conditions studied

• Emotions — all drugs for Emotions →

Sponsor

University Medicine Greifswald

Who can join

Adults 18 to 35, male only, with Emotions. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• hit rate
  Time frame: 90 min after study medication
  number of correctly recognized learned pictures over number of all pictures
• false alarm rate
  Time frame: 90 min after study medication
  number of unlearned pictures incorrectly categorized as old over number of all pictures
• dicrimination index
  Time frame: 90 min after study medication
  hit rate minus false alarm rate
• event-related potentials (ERPs given in µV)
  Time frame: 90 min after study medication
  ERPs were extracted from the continuous electroencephalography signal (EEG). ERPs analyzed during encoding were late positive potentials (LPPs) in the time-range 550-1000 ms after stimulus onset. ERPs analyzed during recognition were late positive complexes (LPCs) for stimuli associated with hit responses (learned pictures correctly recognized as known) and correct rejections (unlearned pictures c

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.