- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857088
Olfactory and Visual Perception in Depressed Patients (PERODEP)
August 2, 2016 updated by: Centre Hospitalier Universitaire de Besancon
Study of the Emotional Reactivity to Olfactive and Visual Perception in Depressed Patients
The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Doubs
-
Besancon, Doubs, France, 25030
- CHU Besançon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: depressed patients
patient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
|
determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
20 images (from the IAPS-international affective picture systems) are presented to the subject.
He has to determine the hedonicity of each picture.
during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity
|
Experimental: non depressed subject
subject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment
|
determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
20 images (from the IAPS-international affective picture systems) are presented to the subject.
He has to determine the hedonicity of each picture.
during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hedonicity score of visual stimuli
Time Frame: up to 1 month
|
it will be compared between depressed and non depressed subjects.
|
up to 1 month
|
skin conductance reactivity amplitude
Time Frame: up to 1 month
|
it will be compared between depressed and non depressed subjects.
|
up to 1 month
|
Skin conductance reactivity reaction time
Time Frame: up to 1 month
|
it will be compared between depressed and non depressed subjects.
|
up to 1 month
|
hedonicity score of olfactory stimuli
Time Frame: up to 1 month
|
it will be compared between depressed and non depressed subjects.
|
up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sylvie Nezelof, MD PhD, Centre Hospitalier Universitaire de Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
July 26, 2016
First Submitted That Met QC Criteria
August 2, 2016
First Posted (Estimate)
August 5, 2016
Study Record Updates
Last Update Posted (Estimate)
August 5, 2016
Last Update Submitted That Met QC Criteria
August 2, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2011/126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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