NCT00570271

Brief 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. 1.Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
  2. 2.The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
  3. 3.This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
  4. 4.The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 10, 2007

Status Verified

November 1, 2007

First QC Date

December 5, 2007

Last Update Submit

December 7, 2007

Conditions

Blood Pressure

Keywords

placebo effectblood pressureautonomic nervous systemprestigebasic research on physiological placebo effects

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure

    60 minutes

Secondary Outcomes (3)

  • Heart rate

    60 minutes

  • skin conductance level

    60 minutes

  • gastric activity

    60 minutes

Study Arms (6)

1

EXPERIMENTAL
Other: Placebo with BP dec (written form)

2

EXPERIMENTAL
Other: Placebo with BP dec (doctor)

3

EXPERIMENTAL
Other: Placebo with BP inc (written)

4

EXPERIMENTAL
Other: Placebo with BP inc (doctor)

5

NO INTERVENTION
Other: Placebo info given (written)

6

NO INTERVENTION
Other: Placebo info given (doc)

Interventions

Placebo with BP dec (written form)OTHER

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

1
Placebo with BP dec (doctor)OTHER

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

2
Placebo with BP inc (written)OTHER

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

3
Placebo with BP inc (doctor)OTHER

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

4
Placebo info given (written)OTHER

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

5
Placebo info given (doc)OTHER

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

6

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychosomatic Medicine and Psychotherapy, Charité University

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Interventions

Desoxycorticosterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Hans-Christian Deter, MD

    Charité University Berlin

    STUDY DIRECTOR

Central Study Contacts

Frank Zimmermann-Viehoff, MD

CONTACT

+49-30-84454046frank.zimmermann@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 10, 2007

Study Start

April 1, 2007

Study Completion

February 1, 2008

Last Updated

December 10, 2007

Record last verified: 2007-11

Locations

DE(1)