MemoryPhase 1NCT00889096
Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects
A Phase 1 study testing propranolol in people with Memory and Heart Rate, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Memory, Heart Rate, Skin Electric Conductance
- What is being tested?
- propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
Greifswald, Mecklenburg-Vorpommern
About this study
- 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.
- 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.
- To evaluate correlations between behavioral data and psychophysiological parameters.
Read the 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.
- Conditions
- Memory, Heart Rate, Skin Electric Conductance, Amylase, Propanolol
- Being tested
- propranolol, placebo
- Keywords
- memory, heart rate, skin conductance, α-amylase, propranolol, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
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.
placeboDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Werner Siegmund, Prof, Principal investigator, Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889096
- Sponsor's protocol ID
- BBEmoMem
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propranolol on the Encoding and Retrieval of Emotional Material After Single Dose Administration in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT00889096
- Acronym / sponsor ID
- BBEmoMem
- Conditions
- Memory, Heart Rate, Skin Electric Conductance, Amylase, Propanolol
- Keywords
- memory, heart rate, skin conductance, α-amylase, propranolol, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- To evaluate correlations between behavioral data and psychophysiological parameters.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study day 1 propanolol | Active comparator | Drug: propranololOral 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. |
| study day 1 placebo | Placebo comparator | Drug: placeboOral 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propranololOral 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. | Drug | study day 1 propanolol |
| placeboOral 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. | Drug | study day 1 placebo |
Primary outcome
memory performance for pictures
5 secondary outcomes
heart rate and heart rate variability
blood pressure
skin conductance and responses electrocortical activity
α-amylase activity in saliva
tolerability of propranolol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
Related trials for Memory
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Siegmund, Prof principal investigator
Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing propranolol in people with Memory and Heart Rate, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memory performance for pictures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.