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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02857088
Other study ID # P/2011/126
Secondary ID
Status Terminated
Phase N/A
First received July 26, 2016
Last updated August 2, 2016
Start date February 2014
Est. completion date April 2016

Study information

Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date April 2016
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
olfactory assessment
determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
image visualization
20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture.
psychophysiological assessment
during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity

Locations

Country Name City State
France CHU Besancon Besancon Doubs

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary hedonicity score of visual stimuli it will be compared between depressed and non depressed subjects. up to 1 month No
Primary skin conductance reactivity amplitude it will be compared between depressed and non depressed subjects. up to 1 month No
Primary Skin conductance reactivity reaction time it will be compared between depressed and non depressed subjects. up to 1 month No
Primary hedonicity score of olfactory stimuli it will be compared between depressed and non depressed subjects. up to 1 month No
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