Back to resultsThe Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Primary Purpose
Major Depressive Episode
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placebo nasal spray
Film sequence
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Episode
Eligibility Criteria
Inclusion Criteria:
- major depression (mild to moderate)
- fluent in German language
Exclusion Criteria:
- 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
Sites / Locations
- Justus Liebig University Gießen
- Philipps University Marburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Positive placebo group
Placebo control group
No-treatment control group
Arm Description
Participants 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.
Participants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness.
Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.
Outcomes
Primary Outcome Measures
Sadness
Items of PANAS-X
Secondary Outcome Measures
Full Information
NCT ID
NCT03190772
First Posted
June 14, 2017
Last Updated
November 6, 2018
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03190772
Brief Title
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Official Title
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Episode
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive placebo group
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Participants receive a placebo nasal spray and are told that it is a placebo. Participants watch a film sequence that is supposed to induce sadness.
Arm Title
No-treatment control group
Arm Type
Other
Arm Description
Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.
Intervention Type
Other
Intervention Name(s)
Placebo nasal spray
Intervention Description
The placebo nasal spray consists of sesame oil and does not contain any active drug.
Intervention Type
Other
Intervention Name(s)
Film sequence
Intervention Description
All groups watch the film sequence that is supposed to induce sadness.
Primary Outcome Measure Information:
Title
Sadness
Description
Items of PANAS-X
Time Frame
Directly after watching the film sequence, no follow-up assessments
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
major depression (mild to moderate)
fluent in German language
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Professor
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Justus Liebig University Gießen
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35390
Country
Germany
Facility Name
Philipps University Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
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