NCT02857088

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

July 26, 2016

Last Update Submit

August 2, 2016

Conditions

Keywords

depressionemotional reactivity

Outcome Measures

Primary Outcomes (4)

  • hedonicity score of visual stimuli

    it will be compared between depressed and non depressed subjects.

    up to 1 month

  • skin conductance reactivity amplitude

    it will be compared between depressed and non depressed subjects.

    up to 1 month

  • Skin conductance reactivity reaction time

    it will be compared between depressed and non depressed subjects.

    up to 1 month

  • hedonicity score of olfactory stimuli

    it will be compared between depressed and non depressed subjects.

    up to 1 month

Study Arms (2)

depressed patients

EXPERIMENTAL

patient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment

Behavioral: olfactory assessmentBehavioral: image visualizationBehavioral: psychophysiological assessment

non depressed subject

EXPERIMENTAL

subject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment

Behavioral: olfactory assessmentBehavioral: image visualizationBehavioral: psychophysiological assessment

Interventions

determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors

depressed patientsnon depressed subject

20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture.

depressed patientsnon depressed subject

during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity

depressed patientsnon depressed subject

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • visual impairment
  • olfactory impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, Doubs, 25030, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sylvie Nezelof, MD PhD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 5, 2016

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations