Back to resultsOlfactory and Visual Perception in Depressed Patients (PERODEP)
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactory assessment
image visualization
psychophysiological assessment
Sponsored by
About this trial
This is an interventional basic science trial for Depression focused on measuring depression, emotional reactivity
Eligibility Criteria
Inclusion Criteria:
- no cognitive impairment that could prevent instruction comprehension
- no more than 10 cigarettes/day
- signed informed consent
- group 1: current major depressive disorder
- group 2: no current major depressive disorder
Exclusion Criteria:
- pregnancy
- visual impairment
- olfactory impairment
Sites / Locations
- CHU Besancon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
depressed patients
non depressed subject
Arm Description
patient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
subject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
Outcomes
Primary Outcome Measures
hedonicity score of visual stimuli
it will be compared between depressed and non depressed subjects.
skin conductance reactivity amplitude
it will be compared between depressed and non depressed subjects.
Skin conductance reactivity reaction time
it will be compared between depressed and non depressed subjects.
hedonicity score of olfactory stimuli
it will be compared between depressed and non depressed subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT02857088
First Posted
July 26, 2016
Last Updated
August 2, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02857088
Brief Title
Olfactory and Visual Perception in Depressed Patients
Acronym
PERODEP
Official Title
Study of the Emotional Reactivity to Olfactive and Visual Perception in Depressed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
unavailable recording device and difficulty of patient inclusions
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, emotional reactivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
depressed patients
Arm Type
Experimental
Arm Description
patient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
Arm Title
non depressed subject
Arm Type
Experimental
Arm Description
subject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
Intervention Type
Behavioral
Intervention Name(s)
olfactory assessment
Intervention Description
determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
Intervention Type
Behavioral
Intervention Name(s)
image visualization
Intervention Description
20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture.
Intervention Type
Behavioral
Intervention Name(s)
psychophysiological assessment
Intervention Description
during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity
Primary Outcome Measure Information:
Title
hedonicity score of visual stimuli
Description
it will be compared between depressed and non depressed subjects.
Time Frame
up to 1 month
Title
skin conductance reactivity amplitude
Description
it will be compared between depressed and non depressed subjects.
Time Frame
up to 1 month
Title
Skin conductance reactivity reaction time
Description
it will be compared between depressed and non depressed subjects.
Time Frame
up to 1 month
Title
hedonicity score of olfactory stimuli
Description
it will be compared between depressed and non depressed subjects.
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no cognitive impairment that could prevent instruction comprehension
no more than 10 cigarettes/day
signed informed consent
group 1: current major depressive disorder
group 2: no current major depressive disorder
Exclusion Criteria:
pregnancy
visual impairment
olfactory impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Nezelof, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Olfactory and Visual Perception in Depressed Patients
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