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Placebo Effects on Blood Pressure
This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, November 2007
Sponsored by: Charite University, Berlin, Germany
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00570271
  Purpose

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:

  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).

Condition Intervention
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)

U.S. FDA Resources
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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Mean arterial pressure [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • skin conductance level [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • gastric activity [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2007
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
1: Experimental Other: Placebo with BP dec (written form)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
2: Experimental Other: Placebo with BP dec (doctor)
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
3: Experimental Other: Placebo with BP inc (written)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
4: Experimental Other: Placebo with BP inc (doctor)
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
5: No Intervention Other: Placebo info given (written)
Subject informed about receiving placebo. Information provided to subjects in written form.
6: No Intervention Other: Placebo info given (doc)
Subject informed about receiving placebo. Information provided to subjects by doctor.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • 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
  • Regular intake of drugs with influence on the autonomic nervous system
  • Insufficient compliance
  • Simultaneous participation in another trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570271

Contacts
Contact: Frank Zimmermann-Viehoff, MD +49-30-84454046 frank.zimmermann@charite.de

Locations
Germany
Department of Psychosomatic Medicine and Psychotherapy, Charité University Recruiting
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Hans-Christian Deter, MD Charité University Berlin
  More Information

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

Keywords provided by Charite University, Berlin, Germany:
placebo effect
blood pressure
autonomic nervous system
prestige
basic research on physiological placebo effects

ClinicalTrials.gov processed this record on January 13, 2009



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