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Trial record 11 of 33793 for:    Placebo AND placebo effect

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

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Change in Positive and Negative Affect Schedule (PANAS) [ Time Frame: Baseline and 45 minutes ]
Change of self-rated sadness
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03507959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Components of Placebo Effects in Sadness
Official Title  ICMJE Components of Placebo Effects in Sadness (COPES): An Experimental Study Comparing Deceptive and Non-deceptive Placebos
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dysphoric Mood
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: OLP scientifically-objective
  • 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.
    Intervention: Other: OLP personally-affective
  • 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.
    Intervention: Other: DP scientifically-objective
  • 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.
    Intervention: Other: DP personally-affective
  • No Intervention: Control group
    This group does not take the nasal spray.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507959
Other Study ID Numbers  ICMJE 2017-40v
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared
Responsible Party Philipps University Marburg Medical Center
Study Sponsor  ICMJE Philipps University Marburg Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tobias Kube, M. Sc. Philipps University Marburg Medical Center
PRS Account Philipps University Marburg Medical Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP