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

NCT ID: NCT03190772

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Major Depressive Episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Placebo nasal spray

Intervention Type OTHER

The placebo nasal spray consists of sesame oil and does not contain any active drug.

Film sequence

Intervention Type OTHER

All groups watch the film sequence that is supposed to induce sadness.

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.

Group Type PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type OTHER

The placebo nasal spray consists of sesame oil and does not contain any active drug.

Film sequence

Intervention Type OTHER

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.

Group Type OTHER

Film sequence

Intervention Type OTHER

All groups watch the film sequence that is supposed to induce sadness.

Interventions

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Placebo nasal spray

The placebo nasal spray consists of sesame oil and does not contain any active drug.

Intervention Type OTHER

Film sequence

All groups watch the film sequence that is supposed to induce sadness.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Winfried Rief

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Winfried Rief, Professor

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

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Justus Liebig University Gießen

Giessen, Hesse, Germany

Site Status

Philipps University Marburg

Marburg, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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2017-12k

Identifier Type: -

Identifier Source: org_study_id

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