The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
1 other identifier
interventional
94
1 country
2
Brief Summary
The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedNovember 7, 2018
November 1, 2018
11 months
June 14, 2017
November 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sadness
Items of PANAS-X
Directly after watching the film sequence, no follow-up assessments
Study Arms (3)
Positive placebo group
EXPERIMENTALParticipants receive a placebo nasal spray. However, they are told that it protects from experiencing negative emotions. Participants watch a film sequence that is supposed to induce sadness.
Placebo control group
PLACEBO COMPARATORParticipants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness.
No-treatment control group
OTHERParticipants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.
Interventions
The placebo nasal spray consists of sesame oil and does not contain any active drug.
All groups watch the film sequence that is supposed to induce sadness.
Eligibility Criteria
You may qualify if:
- major depression (mild to moderate)
- fluent in German language
You may not qualify if:
- bipolar disorder, psychotic disorder, substance dependence
- cardiovascular disease, severe kidney or liver disease, epilepsy
- change of psychotropic medication intake within the last four weeks
- allergic to capsaicin
- allergic to sesame oil
- students in medicine, pharmacy, or psychology in their third year or older
- completed studies in medicine, pharmacy or psychology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Justus Liebig University Gießen
Giessen, Hesse, 35390, Germany
Philipps University Marburg
Marburg, Hesse, 35032, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Winfried Rief, Professor
Philipps University Marburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dr.
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 19, 2017
Study Start
November 1, 2017
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
November 7, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share