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

Sponsor

Philipps University Marburg Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03190772

Collaborator

(none)

Enrollment

Locations

Arms

10.9

Actual Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Episode	Other: Placebo nasal spray Other: Film sequence	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Sadness [Directly after watching the film sequence, no follow-up assessments]
Items of PANAS-X

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Justus Liebig University Gießen	Gießen	Hessen	Germany	35390
2	Philipps University Marburg	Marburg	Hessen	Germany	35032

Sponsors and Collaborators

Philipps University Marburg Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Winfried Rief, Professor Dr., Philipps University Marburg Medical Center

ClinicalTrials.gov Identifier:

NCT03190772

Other Study ID Numbers:

2017-12k

First Posted:

Jun 19, 2017

Last Update Posted:

Nov 7, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Nov 7, 2018