Placebo Effects on Blood Pressure

NCT00570271 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2007-12-10

No results posted yet for this study

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).

Conditions

  • Blood Pressure

Interventions

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.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Hans-Christian Deter, MD · Charité University Berlin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Completion
2008-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570271 on ClinicalTrials.gov