Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2007-04-30
2008-02-29
Brief Summary
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In our study we aim to test the following hypotheses:
1. Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
2. The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
3. This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
4. The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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1
Placebo with BP dec (written form)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
2
Placebo with BP dec (doctor)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
3
Placebo with BP inc (written)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
4
Placebo with BP inc (doctor)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
5
Placebo info given (written)
Subject informed about receiving placebo. Information provided to subjects in written form.
6
Placebo info given (doc)
Subject informed about receiving placebo. Information provided to subjects by doctor.
Interventions
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Placebo with BP dec (written form)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
Placebo with BP dec (doctor)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
Placebo with BP inc (written)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
Placebo with BP inc (doctor)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
Placebo info given (written)
Subject informed about receiving placebo. Information provided to subjects in written form.
Placebo info given (doc)
Subject informed about receiving placebo. Information provided to subjects by doctor.
Eligibility Criteria
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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
* Regular intake of drugs with influence on the autonomic nervous system
* Insufficient compliance
* Simultaneous participation in another trial
18 Years
35 Years
ALL
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin
Principal Investigators
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Hans-Christian Deter, MD
Role: STUDY_DIRECTOR
Charité University Berlin
Locations
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Department of Psychosomatic Medicine and Psychotherapy, Charité University
Berlin, , Germany
Countries
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Central Contacts
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Other Identifiers
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EA4/004/07
Identifier Type: -
Identifier Source: secondary_id
EA4/004/07
Identifier Type: -
Identifier Source: org_study_id