Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects

June 26, 2015 updated by: University Medicine Greifswald
  1. To evaluate the effects of a single oral (80 mg) dose of propranolol on the encoding of emotional pictures as assessed by peripheral physiological and electrocortical parameters in a healthy population.
  2. To evaluate the effects of a single oral (80 mg) dose of propranolol on the retrieval of emotional pictures as assessed by electrocortical parameters in a healthy population.
  3. To evaluate correlations between behavioral data and psychophysiological parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the present study is to combine two lines of research investigating the interaction between emotional processing and memory performance and its modulation by beta-blockade. As has been suggested by aforementioned lesion, pharmacological and neuroimaging evidence, emotional stimuli are better remembered because they are better encoded.

In the ERP literature, there are a number of studies on emotion and memory, but few of them have investigated the modulatory effects of emotion on memory, focusing on either during stages of encoding (Palomba, Angrilli & Mini, 1997; Dolcos & Cabeza, 2002) or during memory retrieval of emotional and neutral material (Maratos & Rugg, 2001; Windmann & Kutas, 2001). It is assumed that emotionally arousing information gains privileged access to processing resources. This means that emotional arousing stimuli guide attention for more elaborated processing, leading to better memory formation.

Concerning pharmacological manipulations with ß-blockers, there is no existing ERP study that shows the effect of ß-blockade on encoding processes and memory retrieval of emotional pictures. Therefore, the current investigation was designed to test whether recall and recognition of emotional pictures can be reduced by administration of propranolol and whether this reduction in memory performance is correlated with changes in event-related potentials or peripheral physiological parameters (heart rate variability, heart rate, blood pressure and electrodermal response). As a surrogate for sympathetic activity and/or activation by noradrenaline, a salivary sample to measure activity of the alpha-amylase will be employed (van Stegeren, Rohleder, Everaerd & Wolf, 2006) In conclusion, we hypothesize (1) a memory advantage for emotionally arousing stimuli but not for emotionally neutral pictures. (2) ERP components associated with emotional effects and memory effects are pronounced for emotional stimuli. (3) Peripheral physiological parameters should also be pronounced for emotionally arousing stimuli. (4) Emotional processing and emotional memory will be impaired by the beta-blocker propranolol as indicated by behavioral data and psycho-physiological parameters.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany
        • Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age: 18 - 35 years
  • sex: male
  • ethnic origin: Caucasian
  • body weight: between 19 kg/m² and 27 kg/m² [calculated from weight (kg)/height2 (m2)]
  • good health as evidenced by the results of the clinical examination, ECG, and laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
  • written informed consent

Exclusion Criteria:

  • obstructive lung disease (e.g. bronchial asthma)
  • peripheral arterial circulatory disturbance
  • any disturbance of impulse formation and conduction (e.g. sick sinus syndrome, SA or AV-blockade)
  • bradycardia (< 50 beats/min)
  • hypotension (systolic pressure < 90 mmHg)
  • existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
  • existing hepatic and renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
  • existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
  • existing or further diseases of the CNS, especially epilepsy
  • acute or chronic diseases which could affect absorption or metabolism
  • history of any serious psychological disorder
  • taking MAO inhibitors
  • drug or alcohol dependence
  • positive drug or alcohol screening
  • smokers
  • positive anti-HIV-test, HBs-Ag-test or anti-HCV-test
  • volunteers who are on a diet which could affect the pharmacokinetics of the drug
  • heavy tea or coffee drinkers (more than 1L per day)
  • volunteers suspected or known not to follow instructions
  • volunteers working night shifts
  • volunteers who are in stressful periods or had undergone major life changes (e.g. death of a close family member in the past year)
  • 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
  • participation in another clinical trial during this study
  • less than 14 days after last acute disease
  • any systemically available medication within 4 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites
  • repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin)
  • repeated use of drugs during the last 2 weeks prior to the intended first administration which affect absorption (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists)
  • known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparation
  • subjects with severe allergies or multiple drug allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study day 1 propanolol
Oral administration of 80 mg propranolol (1 capsule containing two Obsidan® tablets: 2 x 40 mg propranolol) according to randomization list with 240 ml. Determination of blood pressure, heart rate over 4 hours and until return to the initial baseline values.
Drug: propranolol
Oral administration of 80 mg propranolol (1 gelatine capsules; content: 2 tablets of Obsidan® 40 mg Tablets) or placebo (1 gelatine capsules; content: 1 tablet placebo; microcrystalline cellulose, magnesium stearate, cellulose powder, lactose monohydrate) according to randomization list with 240 ml tap water.
Placebo Comparator: study day 1 placebo
Oral administration of placebo (1 capsule containing two placebo tablets) according to randomization list with 240 ml. Determination of blood pressure, heart rate over 4 hours and until return to the initial baseline values.
Drug: placebo
Oral administration of placebo (1 gelatine capsules; content: 1 tablet placebo; microcrystalline cellulose, magnesium stearate, cellulose powder, lactose monohydrate) according to randomization list with 240 ml tap water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
memory performance for pictures

Secondary Outcome Measures

Outcome Measure
blood pressure
heart rate and heart rate variability
skin conductance and responses electrocortical activity
α-amylase activity in saliva
tolerability of propranolol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Principal Investigator: Werner Siegmund, Prof, Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBEmoMem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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