DepressionPERODEPNCT02857088
Olfactory and Visual Perception in Depressed Patients
A study testing olfactory assessment, image visualization and psychophysiological assessment in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- olfactory assessment, image visualization and psychophysiological assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- visual impairment
- olfactory impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- olfactory assessment, image visualization, psychophysiological assessment
- Keywords
- depression, emotional reactivity
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory assessmentBehavioural
determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
image visualizationBehavioural
20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture.
psychophysiological assessmentBehavioural
during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity
| Study group | Role | What they receive |
|---|---|---|
| depressed patients | Experimental | patient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment Receives: Behavioral: olfactory assessment; Behavioral: image visualization; Behavioral: psychophysiological assessment |
| non depressed subject | Experimental | subject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment Receives: Behavioral: olfactory assessment; Behavioral: image visualization; Behavioral: psychophysiological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
hedonicity score of visual stimuli
it will be compared between depressed and non depressed subjects.
Measured: up to 1 month
skin conductance reactivity amplitude
it will be compared between depressed and non depressed subjects.
Measured: up to 1 month
Skin conductance reactivity reaction time
it will be compared between depressed and non depressed subjects.
Measured: up to 1 month
hedonicity score of olfactory stimuli
it will be compared between depressed and non depressed subjects.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2016
Why it stopped: unavailable recording device and difficulty of patient inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Nezelof, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857088
- Sponsor's protocol ID
- P/2011/126
- Acronym
- PERODEP
- Status last verified
- Aug 2016
- First submitted
- 26 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Emotional Reactivity to Olfactive and Visual Perception in Depressed Patients
- ClinicalTrials.gov ID
- NCT02857088
- Acronym / sponsor ID
- PERODEP / P/2011/126
- Conditions
- Depression
- Keywords
- depression, emotional reactivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unavailable recording device and difficulty of patient inclusions
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depressed patients | Experimental | Behavioral: olfactory assessment, Behavioral: image visualization, Behavioral: psychophysiological assessmentpatient with a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment |
| non depressed subject | Experimental | Behavioral: olfactory assessment, Behavioral: image visualization, Behavioral: psychophysiological assessmentsubject without a current unipolar major depressive disorder intervention: olfactory assessment, image visualization and psychophysiological assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- visual impairment
- olfactory impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory assessmentdetermination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors | Behavioural | depressed patients, non depressed subject |
| image visualization20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture. | Behavioural | depressed patients, non depressed subject |
| psychophysiological assessmentduring the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity | Behavioural | depressed patients, non depressed subject |
Primary outcome
hedonicity score of visual stimuli
Time frame: up to 1 month
it will be compared between depressed and non depressed subjects.
skin conductance reactivity amplitude
Time frame: up to 1 month
it will be compared between depressed and non depressed subjects.
Skin conductance reactivity reaction time
Time frame: up to 1 month
it will be compared between depressed and non depressed subjects.
hedonicity score of olfactory stimuli
Time frame: up to 1 month
it will be compared between depressed and non depressed subjects.
Results and safety
The study was stopped early (reason given: unavailable recording device and difficulty of patient inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Nezelof, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory assessment, image visualization and psychophysiological assessment in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unavailable recording device and difficulty of patient inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hedonicity score of visual stimuli (time frame: up to 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.