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Placebo Effects on Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00570271
First received: December 5, 2007
Last updated: December 7, 2007
Last verified: November 2007
History of Changes

December 5, 2007
December 7, 2007
April 2007
Not Provided
Mean arterial pressure [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00570271 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Placebo Effects on Blood Pressure
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:

  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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Blood Pressure
  • Other: Placebo with BP dec (written form)
    Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
  • Other: Placebo with BP dec (doctor)
    Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
  • Other: Placebo with BP inc (written)
    Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
  • Other: Placebo with BP inc (doctor)
    Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
  • Other: Placebo info given (written)
    Subject informed about receiving placebo. Information provided to subjects in written form.
  • Other: Placebo info given (doc)
    Subject informed about receiving placebo. Information provided to subjects by doctor.
  • Experimental: 1
    Intervention: Other: Placebo with BP dec (written form)
  • Experimental: 2
    Intervention: Other: Placebo with BP dec (doctor)
  • Experimental: 3
    Intervention: Other: Placebo with BP inc (written)
  • Experimental: 4
    Intervention: Other: Placebo with BP inc (doctor)
  • No Intervention: 5
    Intervention: Other: Placebo info given (written)
  • No Intervention: 6
    Intervention: Other: Placebo info given (doc)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
February 2008
Not Provided

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
Both
18 Years to 35 Years
Yes
Contact: Frank Zimmermann-Viehoff, MD +49-30-84454046 frank.zimmermann@charite.de
Germany
 
NCT00570271
EA4/004/07, EA4/004/07
No
Prof. Dr. H.-C. Deter, Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin
Charite University, Berlin, Germany
Not Provided
Study Director: Hans-Christian Deter, MD Charité University Berlin
Charite University, Berlin, Germany
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP