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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00570271 |
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:
Condition | Intervention |
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Blood Pressure |
Other: Placebo with BP dec (written form) Other: Placebo with BP dec (doctor) Other: Placebo with BP inc (written) Other: Placebo with BP inc (doctor) Other: Placebo info given (written) Other: Placebo info given (doc) |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure |
Estimated Enrollment: | 90 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Other: Placebo with BP dec (written form)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
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2: Experimental |
Other: Placebo with BP dec (doctor)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
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3: Experimental |
Other: Placebo with BP inc (written)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
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4: Experimental |
Other: Placebo with BP inc (doctor)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
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5: No Intervention |
Other: Placebo info given (written)
Subject informed about receiving placebo. Information provided to subjects in written form.
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6: No Intervention |
Other: Placebo info given (doc)
Subject informed about receiving placebo. Information provided to subjects by doctor.
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frank Zimmermann-Viehoff, MD | +49-30-84454046 | frank.zimmermann@charite.de |
Germany | |
Department of Psychosomatic Medicine and Psychotherapy, Charité University | Recruiting |
Berlin, Germany, 12203 |
Study Director: | Hans-Christian Deter, MD | Charité University Berlin |
Responsible Party: | Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin ( Prof. Dr. H.-C. Deter ) |
Study ID Numbers: | EA4/004/07, EA4/004/07 |
Study First Received: | December 5, 2007 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00570271 |
Health Authority: | Germany: Ethics Commission |
placebo effect blood pressure autonomic nervous system prestige basic research on physiological placebo effects |