Dysphoric MoodCOPESNCT03507959
Components of Placebo Effects in Sadness
A study testing OLP scientifically-objective, OLP personally-affective and DP scientifically-objective in people with Dysphoric Mood, run by Philipps University Marburg at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphoric Mood
- What is being tested?
- OLP scientifically-objective, OLP personally-affective and DP scientifically-objective
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 40 years
- no mental disorder or physical disease
- sufficient German language knowledge
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Components of Placebo Effects in Sadness (COPES): An Experimental Study Comparing Deceptive and Non-deceptive Placebos
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.
Read the 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.
- Conditions
- Dysphoric Mood
- Being tested
- OLP scientifically-objective, OLP personally-affective, DP scientifically-objective, DP personally-affective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLP scientifically-objectiveOther
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-affectiveOther
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-objectiveOther
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-affectiveOther
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 group | Role | What they receive |
|---|---|---|
| OLP scientifically-objective | Experimental | 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. Receives: Other: OLP scientifically-objective |
| OLP personally-affective | Experimental | 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. Receives: Other: OLP personally-affective |
| DP scientifically-objective | Experimental | 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. Receives: Other: DP scientifically-objective |
| DP personally-affective | Experimental | 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. Receives: Other: DP personally-affective |
| Control group | No intervention | This group does not take the nasal spray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect Schedule (PANAS)
Change of self-rated sadness
Measured: Baseline and 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start15 Mar 2018
- Primary completion30 Jun 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphoric MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of five experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Kube, PhD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507959
- Sponsor's protocol ID
- 2017-40v
- Acronym
- COPES
- Status last verified
- Dec 2020
- First submitted
- 7 Mar 2018
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Components of Placebo Effects in Sadness (COPES): An Experimental Study Comparing Deceptive and Non-deceptive Placebos
- ClinicalTrials.gov ID
- NCT03507959
- Acronym / sponsor ID
- COPES / 2017-40v
- Conditions
- Dysphoric Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Participants are assigned to one of five experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| OLP scientifically-objective | Experimental | Other: OLP scientifically-objectiveParticipants 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 | Experimental | Other: OLP personally-affectiveParticipants 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 | Experimental | Other: DP scientifically-objectiveParticipants 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 | Experimental | Other: DP personally-affectiveParticipants 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 | No intervention | –This group does not take the nasal spray. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 40 years
- no mental disorder or physical disease
- sufficient German language knowledge
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLP scientifically-objectiveParticipants 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 |
| OLP personally-affectiveParticipants 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 |
| DP scientifically-objectiveParticipants 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 |
| DP personally-affectiveParticipants 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 |
Primary outcome
Change in Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and 45 minutes
Change of self-rated sadness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No. No IPD will be shared
Related trials for Dysphoric Mood
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Comparative Study of Gender Identity Disorder Versus Control
Gender Dysphoria, Adult
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
RecruitingObservational study
China Gender-affirming Hormone Therapy Study
Transgender, Gender Incongruence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kube, PhD principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLP scientifically-objective, OLP personally-affective and DP scientifically-objective in people with Dysphoric Mood, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect Schedule (PANAS) (time frame: Baseline and 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.