EmotionsPhase 1BBEmoMem_GNCT02509559
Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures
A Phase 1 study testing propranololhydrochloride, Net Station® System and compatible Geodesic Sensor Nets® and VITAPORT in people with Emotions, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The main objective of the present study is to combine two lines of research, investigating the interaction between emotional processing and memory performance (on both behavioral and electrophysiological levels) and its modulation by ß-blockade. 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
- Emotions
- What is being tested?
- propranololhydrochloride, Net Station® System and compatible Geodesic Sensor Nets® and VITAPORT
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jan 2015
- 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
- 18 - 35 years
- male
- caucasian
- body mass index: > 19 kg/m² and < 27 kg/m²
- genotype:
- being homozygote for ADRB2 haplotype 2 (variant allele) and homozygote for ADRB1 c.1165 (CC)
Show all 11Show fewer
- being homozygote for ADRB2 haplotype 2 (variant allele) and homozygote for ADRB1 c.1165 (GG) or heterozygote for ADRB1 c.1165 (CG)
- being homozygote for ADRB2 haplotype 4 (wild-type) and homozygote for ADRB1 c.1165 (CC)
- being homozygote for ADRB2 haplotype 4 (wild-type) and homozygote for ADRB1 c.1165 (GG) or heterozygote for ADRB1 c.1165 (CG)
- good health as evidenced by the results of the clinical examination, ECG, ergometry and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state; the lower limit for systolic pressure is stated with 110 mm Hg and diastolic blood pressure with 70 mmHg as well as heart frequency should not fall below 50 bpm (WHO definition)
- written informed consent
Who cannot join
- sex: female
- hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
- existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. bradycardia, hypotonia, av- block I°)
- volunteers liable to orthostatic dysregulation, fainting, or blackouts
- peripheral circulatory disturbances
- gastrointestinal diseases and/or pathological findings (e.g. stenoses), which might interfere with pharmacokinetics and pharmacodynamics of the study medication
Show all 27Show fewer
- obstructive disorder of breathing (e. g. asthma bronchiale)
- known allergic reactions to the active ingredients used or to constituents of the study medication
- known allergic reactions to any drug therapy in the anamnesis or actual de-allergisation
- psoriasis
- diabetes mellitus
- addiction to hypoglycemia
- pheochromocytoma
- myasthenia gravis
- drug or alcohol dependence
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day
- positive results in HIV, HBV and HCV screenings
- volunteers who are on a diet which could affect the pharmacokinetics of the drug (e. g. vegetarian
- heavy tea or coffee drinkers (more than 1L per day)
- volunteers suspected or known not to follow instructions of the clinical investigators
- 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
- less than 14 days after last acute disease
- any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors, anticholinergics)
- any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-live of the respective drug (except oral contraceptives)
- intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication
- intake of poppy seed containing food or beverages within 14 days prior to administration of the study medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald
Greifswald, Mecklenburg-Vorpommern, 17487
About this study
Official title: Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures After Single Dose (80 mg) Administration and Relationships Between ß1- and ß2-adrenoreceptors Genotype and Both the Information Processing and the Propranolol Effects in 64 Healthy Male Subjects
The main objective of the present study is to combine two lines of research, investigating the interaction between emotional processing and memory performance (on both behavioral and electrophysiological levels) and its modulation by ß-blockade.
Concerning pharmacological manipulations with ß-blockers, there are no studies, which investigated the effects of propranolol on electrophysiological (ERPs) and behavioral measures of recognition memory along with their codependence on individual variations of adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.
Read more
Therefore, the current investigation has been designed to replicate the former results which revealed reduced ERP correlates of recognition memory for emotional pictures due to administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in memory performance and/or changes in event-related potentials and in propranolol influences on the above mentioned processes.
In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP, old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction of electrocortical correlates of emotional recognition memory (old-new effect) caused by propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the emotional information processing and memory formation alone, and on the propranolol modulation of those processes.
Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol such as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary function and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.
- Conditions
- Emotions
- Being tested
- propranololhydrochloride, placebo, Net Station® System and compatible Geodesic Sensor Nets®, VITAPORT, ergoselect II 100/200
- Keywords
- Receptors, Adrenergic, Propranolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololhydrochlorideDrug
Also called propanolol pharmacokinetics
oral administration of one capsule Propanolol-CT 80 mg Filmtabletten (propranololhydrochloride, film-coated tablet encapsulated, 80 mg, single dose) together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3 with subsequent measuring of propranolol and its clinically relevant metabolites
placeboDrug
Also called placebo capsule
oral administration of one placebo capsule together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3
Net Station® System and compatible Geodesic Sensor Nets®Device
Electrocortical activity will be assessed by continuous EEG recording using Net Station® System and compatible Geodesic Sensor Nets® (Electrical Geodesics Incorporated, Eugene, OR, USA), measured at days 1, 3 and 10 of the study. Event related potentials at encoding (late positive potential, LPP) and at retrieval (ERP memory old/new effect) will be computed off-line after acquisition of the data.
VITAPORTDevice
Measurement of the skin conductance by VITAPORT (Vitaport EDV Systeme GmbH, Erftstadt, Germany) on study days 1 and 3 at the time points before administration of the study medication, during the psychophysiological measurement and at 4 h. Furthermore, the skin conductance responses will be measured on day 10 during the psychophysiological measurement.
ergoselect II 100/200Device
Performance of an ergometry by ergoselect II 100/200 (ergoline GmbH, Bitz, Germany) on study days 1 and 3 at 120 min. The burden will be the same wattage over 4 min, that corresponds to that of reaching 80% of the maximal heart frequency in the prestudy examination.
SpiroScoutDevice
Performance of a spirometry (SpiroScout, Ganshorn Medizin Electronic GmbH, Niederlauer, Germany) with measuring of the forced expiratory volume in 1 second (FEV1) on study days 1 and 3 before administration of the study medication and at 120 min.
Mobil-O-Graph® PWADevice
Measurement of pulse waves by Mobil-O-Graph® PWA (I.E.M., Stollberg, Germany) on study days 1 and 3 at the time points -10 min, 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h.
Saliva collectionProcedure or surgery
Saliva collection will be performed on study days 1 and 3 at time points -10 min, 80 min, 120 min with subsequent measuring of the concentration of α -amylase
| Study group | Role | What they receive |
|---|---|---|
| Propanolol | Active comparator | Memory performance for pictures, electrocortical activity, pharmacokinetics, skin-conductance, pulse waves, burdening heart frequency, pulmonary function, α-amylase in saliva, heart rate and blood pressure after administration of one Propranolol-CT 80 mg film-coated tablet. Receives: Drug: propranololhydrochloride; Device: Net Station® System and compatible Geodesic Sensor Nets®; Device: VITAPORT; Device: ergoselect II 100/200; Device: SpiroScout; Device: Mobil-O-Graph® PWA; Procedure: Saliva collection |
| Placebo | Placebo comparator | Memory performance for pictures, electrocortical activity, pharmacokinetics, skin-conductance, pulse waves, burdening heart frequency, pulmonary function, α-amylase in saliva, heart rate and blood pressure after administration of one placebo capsule. Receives: Drug: placebo; Device: Net Station® System and compatible Geodesic Sensor Nets®; Device: VITAPORT; Device: ergoselect II 100/200; Device: SpiroScout; Device: Mobil-O-Graph® PWA; Procedure: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
hit rate
number of correctly recognized learned pictures over number of all pictures
Measured: 90 min after study medication
false alarm rate
number of unlearned pictures incorrectly categorized as old over number of all pictures
Measured: 90 min after study medication
dicrimination index
hit rate minus false alarm rate
Measured: 90 min after study medication
event-related potentials (ERPs given in µV)
ERPs were extracted from the continuous electroencephalography signal (EEG). ERPs analyzed during encoding were late positive potentials (LPPs) in the time-range 550-1000 ms after stimulus onset. ERPs analyzed during recognition were late positive complexes (LPCs) for stimuli associated with hit responses (learned pictures correctly recognized as known) and correct rejections (unlearned pictures correctly categorized as unknown) in time range 550-700 ms after stimulus onset. Subtraction of amplitude values for both types of LPCs results in ERP old/new effects.
Measured: 90 min after study medication
Secondary outcomes (8)
Forced Expiratory Volume in 1 second (FEV 1)
Measured: up to 10 min before and 2 h after study medication
Skin Conductance Response (SCR in the time-window up to 6.5 s after stimulus onset, in µmho)
The skin conductance will be measured between two electrodes attached to the participant's palm. SCRs will be averaged for every participant over following conditions: unpleasant, neutral and pleasant during encoding; and unpleasant old, neutral old, pleasant old, unpleasant new, neutral new, and pleasant new during recognition.
Measured: up to 10 min before and 90 min and 4 h after study medication
heart rate
Measured: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
systolic blood pressure (mmHg)
Measured: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
diastolic blood pressure (mmHg)
Measured: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
α-amylase activity in saliva
concentration in U/ml
Measured: up to 1 min before and 80 min and 2 h after study medication
skin conductance level (SCL, in mikroSiemens over a time range of 120 s [µmho])
The skin conductance will be measured between two electrodes attached to the participant's palm.
Measured: up to 10 min before and 90 min and 4 h after study medication
mean arterial pressure (MAP)
It is defined as the average arterial pressure during a single cardiac cycle.
Measured: up to 10 min before and 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h after study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Siegmund, Prof, Principal investigator, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509559
- Sponsor's protocol ID
- BBEmoMem_G
- Acronym
- BBEmoMem_G
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propranolol (vs. Placebo) on Information Processing During Presentation of Emotionally Arousing Pictures After Single Dose (80 mg) Administration and Relationships Between ß1- and ß2-adrenoreceptors Genotype and Both the Information Processing and the Propranolol Effects in 64 Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02509559
- Acronym / sponsor ID
- BBEmoMem_G / BBEmoMem_G
- Conditions
- Emotions
- Keywords
- Receptors, Adrenergic, Propranolol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Jul 2015 (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.
The main objective of the present study is to combine two lines of research, investigating the interaction between emotional processing and memory performance (on both behavioral and electrophysiological levels) and its modulation by ß-blockade.
Concerning pharmacological manipulations with ß-blockers, there are no studies, which investigated the effects of propranolol on electrophysiological (ERPs) and behavioral measures of recognition memory along with their codependence on individual variations of adrenergic receptors' polymorphisms. Till now, also the findings about genetic influences of ADRB1 and ADRB2 on recognition memory for emotional contents are lacking.
Therefore, the current investigation has been designed to replicate the former results which revealed reduced ERP correlates of recognition memory for emotional pictures due to administration of ß-blocker propranolol. Furthermore investigators goal is to test, whether there are any differences between carriers of genetic variants of the ADRB1 and ADRB2 in memory performance and/or changes in event-related potentials and in propranolol influences on the above mentioned processes.
In conclusion, investigators hypothesize: (1) a memory advantage of emotionally arousing stimuli over emotionally neutral pictures; (2) more pronounced ERP components (EPN, LPP, old-new effect) associated with encoding and memory for emotional stimuli; (3) a reduction of electrocortical correlates of emotional recognition memory (old-new effect) caused by propranolol; (4) a potential impact of genetic variants of the ADRB1 and ADRB2 on the emotional information processing and memory formation alone, and on the propranolol modulation of those processes.
Furthermore, investigators hypothesize additional pharmacodynamic effects of propranolol such as influence on skin- conductance, pulse waves, burdening heart frequency, pulmonary function and metabolomics, which might depend on the ADRB1 and ADRB2 genotype.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propanolol | Active comparator | Drug: propranololhydrochloride, Device: Net Station® System and compatible Geodesic Sensor Nets®, Device: VITAPORT, Device: ergoselect II 100/200, Device: SpiroScout, Device: Mobil-O-Graph® PWA, Procedure: Saliva collectionMemory performance for pictures, electrocortical activity, pharmacokinetics, skin-conductance, pulse waves, burdening heart frequency, pulmonary function, α-amylase in saliva, heart rate and blood pressure after administration of one Propranolol-CT 80 mg film-coated tablet. |
| Placebo | Placebo comparator | Drug: placebo, Device: Net Station® System and compatible Geodesic Sensor Nets®, Device: VITAPORT, Device: ergoselect II 100/200, Device: SpiroScout, Device: Mobil-O-Graph® PWA, Procedure: Saliva collectionMemory performance for pictures, electrocortical activity, pharmacokinetics, skin-conductance, pulse waves, burdening heart frequency, pulmonary function, α-amylase in saliva, heart rate and blood pressure after administration of one placebo capsule. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18 - 35 years
- male
- caucasian
- body mass index: > 19 kg/m² and < 27 kg/m²
- genotype:
Key exclusion criteria (27 listed)
- sex: female
- hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication
- existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. bradycardia, hypotonia, av- block I°)
- volunteers liable to orthostatic dysregulation, fainting, or blackouts
- peripheral circulatory disturbances
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 |
|---|---|---|
| propranololhydrochlorideAlso: propanolol pharmacokineticsoral administration of one capsule Propanolol-CT 80 mg Filmtabletten (propranololhydrochloride, film-coated tablet encapsulated, 80 mg, single dose) together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3 with subsequent measuring of propranolol and its clinically relevant metabolites | Drug | Propanolol |
| placeboAlso: placebo capsuleoral administration of one placebo capsule together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3 | Drug | Placebo |
| Net Station® System and compatible Geodesic Sensor Nets®Electrocortical activity will be assessed by continuous EEG recording using Net Station® System and compatible Geodesic Sensor Nets® (Electrical Geodesics Incorporated, Eugene, OR, USA), measured at days 1, 3 and 10 of the study. Event related potentials at encoding (late positive potential, LPP) and at retrieval (ERP memory old/new effect) will be computed off-line after acquisition of the data. | Device | Placebo, Propanolol |
| VITAPORTMeasurement of the skin conductance by VITAPORT (Vitaport EDV Systeme GmbH, Erftstadt, Germany) on study days 1 and 3 at the time points before administration of the study medication, during the psychophysiological measurement and at 4 h. Furthermore, the skin conductance responses will be measured on day 10 during the psychophysiological measurement. | Device | Placebo, Propanolol |
| ergoselect II 100/200Performance of an ergometry by ergoselect II 100/200 (ergoline GmbH, Bitz, Germany) on study days 1 and 3 at 120 min. The burden will be the same wattage over 4 min, that corresponds to that of reaching 80% of the maximal heart frequency in the prestudy examination. | Device | Placebo, Propanolol |
| SpiroScoutPerformance of a spirometry (SpiroScout, Ganshorn Medizin Electronic GmbH, Niederlauer, Germany) with measuring of the forced expiratory volume in 1 second (FEV1) on study days 1 and 3 before administration of the study medication and at 120 min. | Device | Placebo, Propanolol |
| Mobil-O-Graph® PWAMeasurement of pulse waves by Mobil-O-Graph® PWA (I.E.M., Stollberg, Germany) on study days 1 and 3 at the time points -10 min, 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h. | Device | Placebo, Propanolol |
| Saliva collectionSaliva collection will be performed on study days 1 and 3 at time points -10 min, 80 min, 120 min with subsequent measuring of the concentration of α -amylase | Procedure or surgery | Placebo, Propanolol |
Primary outcome
hit rate
Time frame: 90 min after study medication
number of correctly recognized learned pictures over number of all pictures
false alarm rate
Time frame: 90 min after study medication
number of unlearned pictures incorrectly categorized as old over number of all pictures
dicrimination index
Time frame: 90 min after study medication
hit rate minus false alarm rate
event-related potentials (ERPs given in µV)
Time frame: 90 min after study medication
ERPs were extracted from the continuous electroencephalography signal (EEG). ERPs analyzed during encoding were late positive potentials (LPPs) in the time-range 550-1000 ms after stimulus onset. ERPs analyzed during recognition were late positive complexes (LPCs) for stimuli associated with hit responses (learned pictures correctly recognized as known) and correct rejections (unlearned pictures correctly categorized as unknown) in time range 550-700 ms after stimulus onset. Subtraction of amplitude values for both types of LPCs results in ERP old/new effects.
8 secondary outcomes
Forced Expiratory Volume in 1 second (FEV 1)
Time frame: up to 10 min before and 2 h after study medication
Skin Conductance Response (SCR in the time-window up to 6.5 s after stimulus onset, in µmho)
Time frame: up to 10 min before and 90 min and 4 h after study medication
heart rate
Time frame: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
systolic blood pressure (mmHg)
Time frame: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
diastolic blood pressure (mmHg)
Time frame: up to 1 min before and 20, 40, 60, 80 min, 2, 3, 5, 7 and 11 h after study medication and during ergometry (0-2 min and 2-4 min) 2 h after study medication
α-amylase activity in saliva
Time frame: up to 1 min before and 80 min and 2 h after study medication
skin conductance level (SCL, in mikroSiemens over a time range of 120 s [µmho])
Time frame: up to 10 min before and 90 min and 4 h after study medication
mean arterial pressure (MAP)
Time frame: up to 10 min before and 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h after study medication
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 28 Jul 2015.
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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
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 propranololhydrochloride, Net Station® System and compatible Geodesic Sensor Nets® and VITAPORT in people with Emotions, 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 11 inclusion and 27 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 28 Jul 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?
hit rate (time frame: 90 min after study medication). The study lists 4 primary outcomes in all. 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 28 Jul 2015.