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Components of Placebo Effects in Sadness

NCT ID: NCT03507959

Last Updated: 2020-12-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2020-01-31

Brief Summary

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Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine components of open-label placebos and traditional deceptive placebos in an experimental study investigating sadness.

Detailed Description

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A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials.

However, comparisons between OLP and deceptive placebos (DP) with regard to their particular mechanisms are lacking. Therefore, the current study aims to identify components of OLP and DP. For this purpose, experimentally induced sadness is examined using a standardized paradigm which has previously been developed by our working group. In particular, healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. Sadness is assessed before and after receiving a nasal spray. Two experimental groups (DP groups) are informed that they would receive an antidepressant nasal spray, another two experimental groups (OLP groups) are informed that they would receive a placebo. In fact, all nasal sprays are active placebos inducing prickling nasal sensations (sesame oil with 0.014% capsaicin). In addition to the factor "Transparency" (DP vs. OLP), the instruction is experimentally varied, with which the substance is administered (scientifically-objective vs. personally-affective), resulting in a 2x2 design. Further, there is an additional fifth group receiving no intervention. The primary outcome is self-rated sadness after taking the nasal spray.

Conditions

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Dysphoric Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of five experimental groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
With regard to the four treatment groups, the investigator is not aware which experimental condition participants were allocated to. Regarding the control group, masking is not feasible.

Study Groups

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OLP scientifically-objective

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.

Group Type EXPERIMENTAL

OLP scientifically-objective

Intervention Type OTHER

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.

OLP personally-affective

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.

Group Type EXPERIMENTAL

OLP personally-affective

Intervention Type OTHER

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.

DP scientifically-objective

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.

Group Type EXPERIMENTAL

DP scientifically-objective

Intervention Type OTHER

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.

DP personally-affective

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.

Group Type EXPERIMENTAL

DP personally-affective

Intervention Type OTHER

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.

Control group

This group does not take the nasal spray.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OLP scientifically-objective

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.

Intervention Type OTHER

OLP personally-affective

Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.

Intervention Type OTHER

DP scientifically-objective

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.

Intervention Type OTHER

DP personally-affective

Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 40 years
* no mental disorder or physical disease
* sufficient German language knowledge

Exclusion Criteria

* intake of psychopharmacological drugs
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* allergy to capsaicin or sesame
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Kube, PhD

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

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Philipps-University of Marburg

Marburg, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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2017-40v

Identifier Type: -

Identifier Source: org_study_id