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

The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.

Study Overview

• Status: Completed
• Conditions: Major Depressive Episode
• Intervention / Treatment: Other: Placebo nasal spray; Other: Film sequence

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany, 35390
      • Justus Liebig University Giessen
    • Marburg, Hessen, Germany, 35032
      • Philipps University Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No-treatment control group; Participants do not receive the nasal spray. Participants watch a film sequence that is supposed to induce sadness.	Other: Film sequence; All groups watch the film sequence that is supposed to induce sadness.
Experimental: Positive placebo group; 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.	Other: Placebo nasal spray; The placebo nasal spray consists of sesame oil and does not contain any active drug.; Other: Film sequence; All groups watch the film sequence that is supposed to induce sadness.
Placebo Comparator: Placebo control group; 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.	Other: Placebo nasal spray; The placebo nasal spray consists of sesame oil and does not contain any active drug.; Other: Film sequence; All groups watch the film sequence that is supposed to induce sadness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sadness	Items of PANAS-X	Directly after watching the film sequence, no follow-up assessments

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Professor, Philipps University Marburg Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2017-12k

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No