The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation

Not Applicable

Completed

• Conditions: Major Depressive Episode
• Interventions: Other: Placebo nasal spray; Other: Film sequence

• Registration Number: NCT03190772
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-19
• Study Start: 2017-11-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control group	Placebo nasal spray	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.
No-treatment control group	Film sequence	Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.
Positive placebo group	Placebo nasal spray	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.
Positive placebo group	Film sequence	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.
Placebo control group	Film sequence	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.

Primary Outcome Measures

Name	Time	Method
Sadness	Directly after watching the film sequence, no follow-up assessments	Items of PANAS-X

Trial Locations

Locations (2)

Philipps University Marburg; 🇩🇪 Marburg, Hessen, Germany

Justus Liebig University Gießen; 🇩🇪 Gießen, Hessen, Germany