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

Status:

COMPLETED

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

Lead Sponsor:

University Medicine Greifswald

Conditions:

Memory

Heart Rate

Eligibility:

MALE

18-35 years

Phase:

PHASE1

Brief 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 popula...

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 ha...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00889096

Last Update

June 29 2015

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