Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03507959
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2018-03-07
Brief Title:
Components of Placebo Effects in Sadness
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Components of Placebo Effects in Sadness COPES An Experimental Study Comparing Deceptive and Non-deceptive Placebos
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPES
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 0014 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
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 0014 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None