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

NCT00889096 | Completed Phase 1

• 1 other identifier: BBEmoMem
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.To evaluate correlations between behavioral data and psychophysiological parameters.

Conditions

Memory; Heart Rate; Skin Electric Conductance; Amylase; Propanolol

Keywords

memory; heart rate; skin conductance; α-amylase; propranolol; tolerability

Outcome Measures

Primary Outcomes (1)

• memory performance for pictures

Secondary Outcomes (5)

• heart rate and heart rate variability

• blood pressure

• skin conductance and responses electrocortical activity

• α-amylase activity in saliva

• tolerability of propranolol

Study Arms (2)

study day 1 propanolol

ACTIVE COMPARATOR

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

study day 1 placebo

PLACEBO COMPARATOR

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

Interventions

propranolol DRUG

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.

study day 1 propanolol

placebo DRUG

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.

study day 1 placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Location

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Werner Siegmund, Prof

  Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Last Updated: June 29, 2015

Record last verified: 2009-04

Locations

DE (1)