Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT03507959
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2018-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Components of Placebo Effects in Sadness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of five experimental groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Positive and Negative Affect Schedule (PANAS)', 'timeFrame': 'Baseline and 45 minutes', 'description': 'Change of self-rated sadness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphoric Mood']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 40 years\n* no mental disorder or physical disease\n* sufficient German language knowledge\n\nExclusion Criteria:\n\n* intake of psychopharmacological drugs\n* intake of illegal drugs in the last two weeks\n* consumption of alcohol in the last twelve hours\n* allergy to capsaicin or sesame'}, 'identificationModule': {'nctId': 'NCT03507959', 'acronym': 'COPES', 'briefTitle': 'Components of Placebo Effects in Sadness', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Components of Placebo Effects in Sadness (COPES): An Experimental Study Comparing Deceptive and Non-deceptive Placebos', 'orgStudyIdInfo': {'id': '2017-40v'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OLP scientifically-objective', 'description': '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.', 'interventionNames': ['Other: OLP scientifically-objective']}, {'type': 'EXPERIMENTAL', 'label': 'OLP personally-affective', 'description': '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.', 'interventionNames': ['Other: OLP personally-affective']}, {'type': 'EXPERIMENTAL', 'label': 'DP scientifically-objective', 'description': '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.', 'interventionNames': ['Other: DP scientifically-objective']}, {'type': 'EXPERIMENTAL', 'label': 'DP personally-affective', 'description': '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.', 'interventionNames': ['Other: DP personally-affective']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group does not take the nasal spray.'}], 'interventions': [{'name': 'OLP scientifically-objective', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['OLP scientifically-objective']}, {'name': 'OLP personally-affective', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['OLP personally-affective']}, {'name': 'DP scientifically-objective', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['DP scientifically-objective']}, {'name': 'DP personally-affective', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['DP personally-affective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35032', 'city': 'Marburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Philipps-University of Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Tobias Kube, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philipps University Marburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}