Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects
Information source: University Medicine Greifswald
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Memory; Heart Rate; Skin Electric Conductance; Amylase; Propanolol
Intervention: propranolol (Drug); placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University Medicine Greifswald Official(s) and/or principal investigator(s): Werner Siegmund, Prof, Principal Investigator, Affiliation: Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
Summary
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.
Clinical Details
Official title: Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: memory performance for pictures
Secondary outcome: heart rate and heart rate variabilityblood pressure skin conductance and responses electrocortical activity α-amylase activity in saliva tolerability of propranolol
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany
Additional Information
Last updated: June 26, 2015
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