ClinicalTrials.gg
Status unknownNCT00570271Updated Dec 10, 2007

Placebo Effects on Blood Pressure

An interventional study of Placebo with BP dec (written form) and Placebo with BP dec (doctor) in Blood Pressure, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-12-10.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

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).
02

Conditions studied

  • Blood Pressure

Keywords

  • placebo effect
  • blood pressure
  • autonomic nervous system
  • prestige
  • basic research on physiological placebo effects
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Informed consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    1

    Other: Placebo with BP dec (written form)

  • Experimental
    2

    Other: Placebo with BP dec (doctor)

  • Experimental
    3

    Other: Placebo with BP inc (written)

  • Experimental
    4

    Other: Placebo with BP inc (doctor)

  • No intervention
    5

    Other: Placebo info given (written)

  • No intervention
    6

    Other: Placebo info given (doc)

Interventions

  • OtherPlacebo with BP dec (written form)

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

  • OtherPlacebo with BP dec (doctor)

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

  • OtherPlacebo with BP inc (written)

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

  • OtherPlacebo with BP inc (doctor)

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

  • OtherPlacebo info given (written)

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

  • OtherPlacebo info given (doc)

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

06

What researchers measure

Primary outcomes

  1. Mean arterial pressure

    Time frame: 60 minutes

Secondary outcomes

  1. Heart rate

    Time frame: 60 minutes

  2. skin conductance level

    Time frame: 60 minutes

  3. gastric activity

    Time frame: 60 minutes

07

Study locations

1 of 1 sites recruiting
  • Department of Psychosomatic Medicine and Psychotherapy, Charité University
    Berlin, 12203, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2007 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2007
First posted
Dec 10, 2007
Start
Apr 2007
CompletionEst.
Feb 2008
Last update
Dec 10, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00570271
First posted
Dec 10, 2007
Start date
Apr 2007
Completion
Feb 2008 (estimated)
Last update
Dec 10, 2007

Study contacts

Frank Zimmermann-Viehoff, MD
Contact
frank.zimmermann@charite.de
+49-30-84454046
Hans-Christian Deter, MD
study director · Charité University Berlin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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