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


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This study is not yet open for participant recruitment.

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Verified June 2017 by Winfried Rief, Philipps University Marburg Medical Center

Sponsor:

Information provided by (Responsible Party):

Winfried Rief, Philipps University Marburg Medical Center

ClinicalTrials.gov Identifier:

NCT03190772

First received: June 14, 2017

Last updated: June 14, 2017

Last verified: June 2017

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

Major Depressive Episode Other: Placebo nasal spray Other: Film sequence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Basic Science
Official Title: The Role of Expectations in the Pharmacological Treatment of Depression – An Experimental Investigation

Primary Outcome Measures:

  • Sadness [ Time Frame: Directly after watching the film sequence, no follow-up assessments ]

    Items of PANAS-X

Estimated Enrollment: 96
Anticipated Study Start Date: July 1, 2017
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190772

Justus Liebig University Gießen
Gießen, Hessen, Germany, 35390
Contact: Christiane Hermann, Professor    +49 641 99 26081    christiane.hermann@psychol.uni-giessen.de   
Contact: Alexander Winkler, PhD    +49 641 99 26084    alexander.winkler@psychol.uni-giessen.de   
Philipps University Marburg
Marburg, Hessen, Germany, 35032
Contact: Winfried Rief, Professor         
Contact: Bettina Doering, PhD         

Philipps University Marburg Medical Center

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

Responsible Party: Winfried Rief, Professor Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03190772     History of Changes
Other Study ID Numbers: 2017-12k
Study First Received: June 14, 2017
Last Updated: June 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 19, 2017