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Components of Placebo Effects in Sadness (COPES)

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ClinicalTrials.gov Identifier: NCT03507959
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysphoric Mood Other: OLP scientifically-objective Other: OLP personally-affective Other: DP scientifically-objective Other: DP personally-affective Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of five experimental groups in parallel for the duration of the study
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Components of Placebo Effects in Sadness (COPES): An Experimental Study Comparing Deceptive and Non-deceptive Placebos
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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.
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.

Experimental: 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.
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.

Experimental: 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.
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.

No Intervention: Control group
This group does not take the nasal spray.



Primary Outcome Measures :
  1. Change in Positive and Negative Affect Schedule (PANAS) [ Time Frame: Baseline and 45 minutes ]
    Change of self-rated sadness



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507959


Contacts
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Contact: Tobias Kube, M. Sc. +49 64212823341 tobias.kube@staff.uni-marburg.de
Contact: Winfried Rief, PhD +49 6421 282 3657 rief@staff.uni-marburg.de

Locations
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Germany
Philipps-University of Marburg Recruiting
Marburg, Hessen, Germany, 35032
Contact: Tobias Kube, PhD    +49 6421 2823341    tobias.kube@staff.uni-marburg.de   
Contact: Winfried Rief, Prof, PhD    +49 6421 282 3657    rief@staff.uni-marburg.de   
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Tobias Kube, M. Sc. Philipps University Marburg Medical Center

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03507959     History of Changes
Other Study ID Numbers: 2017-40v
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs