Placebo Effects on Blood Pressure

Blood Pressure Clinical Trial

Official title:

Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00570271
• Other study ID #: EA4/004/07
• Secondary ID: EA4/004/07
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2007
• Last updated: December 7, 2007
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2007
• Source: Charite University, Berlin, Germany
• Contact: Frank Zimmermann-Viehoff, MD
• Phone: +49-30-84454046
• Email: frank.zimmermann[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine and Psychotherapy, Charité University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure		60 minutes	No
Secondary	Heart rate		60 minutes	No
Secondary	skin conductance level		60 minutes	No
Secondary	gastric activity		60 minutes	No