Blood PressureNCT00570271
Placebo Effects on Blood Pressure
A study of Blood Pressure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Feb 2008
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
Who cannot join
- Not meeting inclusion criteria
- Untreated hypertension (BP > 140/90) or hypotension(BP < 100/60)
- Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
- Diseases with influence on cardiovascular or gastrointestinal system
- Pregnancy and lactation phase
- Body mass index > 30
Show all 9Show fewer
- Regular intake of drugs with influence on the autonomic nervous system
- Insufficient compliance
- Simultaneous participation in another trial
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychosomatic Medicine and Psychotherapy, Charité University
Berlin, 12203
About this study
Official title: Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure
A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. However, it is not fully understood whether these effects are due to a global reaction of the autonomous nervous system (affecting the overall organ systems of the body) or a specific reaction (affecting the cardiovascular system only). We therefore aim to differentiate specific effects (reduction of blood pressure) from global effects (e.g. changes in electrodermal and gastric activity).
In our study we aim to test the following hypotheses:
- Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
- The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
- This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
- The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
- Conditions
- Blood Pressure
- Being tested
- Placebo with BP dec (written form), Placebo with BP dec (doctor), Placebo with BP inc (written), Placebo with BP inc (doctor), Placebo info given (written)
- Keywords
- placebo effect, blood pressure, autonomic nervous system, prestige, basic research on physiological placebo effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo with BP dec (written form)Other
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
Placebo with BP dec (doctor)Other
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
Placebo with BP inc (written)Other
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
Placebo with BP inc (doctor)Other
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
Placebo info given (written)Other
Subject informed about receiving placebo. Information provided to subjects in written form.
Placebo info given (doc)Other
Subject informed about receiving placebo. Information provided to subjects by doctor.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Placebo with BP dec (written form) |
| 2 | Experimental | Not described Receives: Other: Placebo with BP dec (doctor) |
| 3 | Experimental | Not described Receives: Other: Placebo with BP inc (written) |
| 4 | Experimental | Not described Receives: Other: Placebo with BP inc (doctor) |
| 5 | No intervention | Not described Receives: Other: Placebo info given (written) |
| 6 | No intervention | Not described Receives: Other: Placebo info given (doc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Measured: 60 minutes
Secondary outcomes (3)
Heart rate
Measured: 60 minutes
skin conductance level
Measured: 60 minutes
gastric activity
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startApr 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Christian Deter, MD, Study director, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570271
- Sponsor's protocol ID
- EA4/004/07
- Other IDs
- EA4/004/07
- Status last verified
- Nov 2007
- First submitted
- 5 Dec 2007
- Last updated
- 10 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure
- ClinicalTrials.gov ID
- NCT00570271
- Acronym / sponsor ID
- EA4/004/07
- Conditions
- Blood Pressure
- Keywords
- placebo effect, blood pressure, autonomic nervous system, prestige, basic research on physiological placebo effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Feb 2008 (estimated)
- First posted
- 10 Dec 2007 (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.
A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. However, it is not fully understood whether these effects are due to a global reaction of the autonomous nervous system (affecting the overall organ systems of the body) or a specific reaction (affecting the cardiovascular system only). We therefore aim to differentiate specific effects (reduction of blood pressure) from global effects (e.g. changes in electrodermal and gastric activity).
In our study we aim to test the following hypotheses:
- Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
- The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
- This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
- The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Placebo with BP dec (written form) |
| 2 | Experimental | Other: Placebo with BP dec (doctor) |
| 3 | Experimental | Other: Placebo with BP inc (written) |
| 4 | Experimental | Other: Placebo with BP inc (doctor) |
| 5 | No intervention | Other: Placebo info given (written) |
| 6 | No intervention | Other: Placebo info given (doc) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Informed consent
Key exclusion criteria (9 listed)
- Not meeting inclusion criteria
- Untreated hypertension (BP > 140/90) or hypotension(BP < 100/60)
- Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
- Diseases with influence on cardiovascular or gastrointestinal system
- Pregnancy and lactation phase
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 |
|---|---|---|
| Placebo with BP dec (written form)Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form. | Other | 1 |
| Placebo with BP dec (doctor)Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor. | Other | 2 |
| Placebo with BP inc (written)Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form. | Other | 3 |
| Placebo with BP inc (doctor)Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor. | Other | 4 |
| Placebo info given (written)Subject informed about receiving placebo. Information provided to subjects in written form. | Other | 5 |
| Placebo info given (doc)Subject informed about receiving placebo. Information provided to subjects by doctor. | Other | 6 |
Primary outcome
Mean arterial pressure
Time frame: 60 minutes
3 secondary outcomes
Heart rate
Time frame: 60 minutes
skin conductance level
Time frame: 60 minutes
gastric activity
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2007.
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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.
Hans-Christian Deter, MD study director
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Blood Pressure, run by Charite University, Berlin, Germany 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Dec 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Zimmermann-Viehoff, MD (+49-30-84454046, frank.zimmermann@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: 60 minutes). 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 10 Dec 2007.