Placebo Effects on Blood Pressure

NCT ID: NCT00570271

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Blood Pressure

Keywords

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placebo effect blood pressure autonomic nervous system prestige basic research on physiological placebo effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Placebo with BP dec (written form)

Intervention Type OTHER

Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.

2

Group Type EXPERIMENTAL

Placebo with BP dec (doctor)

Intervention Type OTHER

Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.

3

Group Type EXPERIMENTAL

Placebo with BP inc (written)

Intervention Type OTHER

Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.

4

Group Type EXPERIMENTAL

Placebo with BP inc (doctor)

Intervention Type OTHER

Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.

5

Group Type NO_INTERVENTION

Placebo info given (written)

Intervention Type OTHER

Subject informed about receiving placebo. Information provided to subjects in written form.

6

Group Type NO_INTERVENTION

Placebo info given (doc)

Intervention Type OTHER

Subject informed about receiving placebo. Information provided to subjects by doctor.

Interventions

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Placebo with BP dec (written form)

Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.

Intervention Type OTHER

Placebo with BP dec (doctor)

Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.

Intervention Type OTHER

Placebo with BP inc (written)

Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.

Intervention Type OTHER

Placebo with BP inc (doctor)

Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.

Intervention Type OTHER

Placebo info given (written)

Subject informed about receiving placebo. Information provided to subjects in written form.

Intervention Type OTHER

Placebo info given (doc)

Subject informed about receiving placebo. Information provided to subjects by doctor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dept of Psychosomatic Medicine and Psychotherapy, Benjamin Franklin Campus, Charité,Berlin

Principal Investigators

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Hans-Christian Deter, MD

Role: STUDY_DIRECTOR

Charité University Berlin

Locations

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Department of Psychosomatic Medicine and Psychotherapy, Charité University

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Frank Zimmermann-Viehoff, MD

Role: CONTACT

Phone: +49-30-84454046

Email: [email protected]

Other Identifiers

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EA4/004/07

Identifier Type: -

Identifier Source: secondary_id

EA4/004/07

Identifier Type: -

Identifier Source: org_study_id