Major DepressionMOODDISNCT03060967
Assessment of Hedonic and Motivational States in Major Depression ( MOODDIS)
A study testing Computer-based tasks in people with Major Depression, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Computer-based tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2017to 12 Jul 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Depressed patient group
- to be between 20- and 60-year-old;
- to meet the DSM-5 diagnostic criteria for major depressive disorder;
- to experience moderate to severe symptoms interfering with the daily functioning, as indicated by a score above 20 on the Montgomery and Asberg depression scale (MADRS);
- to understand and accept the experimental procedure and constraints of the present study;
- to give written consent for the participation to the study; and,
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- to be a beneficiary of or affiliated to a health insurance plan.
- Healthy volunteer group
- to be between 20- and 60-year-old;
- to be free from any history of psychiatric disorder (substance abuse or alcohol abuse, dependence, mood disorders, etc.) that may require the prescription of long-term psychotropic treatment;
- to understand and accept the experimental procedure and constraints of the study;
- 3) to give written consent for the participation to the study; and, 4) to be a beneficiary of or affiliated to a health insurance plan
Who cannot join
- Depressed patient group
- to have a previous history of somatic disease (hypertensive heart disease, Raynaud's syndrome, diabetes, adrenal insufficiency, Cushing's syndrome, peripheral neuropathy, epilepsy ...) or requiring long-term corticosteroid therapy;
- to experience serious visual disturbances affecting the visual perception of colors;
- to meet the DSM-5 diagnostic criteria for a primary psychiatric disorder such as bipolar disorder, schizophrenia, substance abuse / dependence or alcohol abuse, except for social phobia and generalized anxiety disorder that are commonly comorbid to major depression;
- to exhibit a moderate or high suicidal risk, assessed by using the corresponding section of the so-called structured diagnostic psychiatric interview "Mini International Neuropsychiatric Interview" (M.I.N.I. 6.0);
- to be exposed to the initiation of an antidepressant treatment with either a selective serotonin reuptake inhibitor or a dual serotonin-norepinephrine reuptake inhibitor within the week prior to the study or to be exposed to a change in the daily dosage of such an ongoing antidepressant treatment within the week preceding the study due to its potential sedative and orexigenic properties;
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- to be exposed to an antidepressant treatment with antagonists at the presynaptic alpha-2 norepinephrine receptors or with tricyclic agents within the week prior to the study due to their potential sedative and orexigenic properties related to their anti-H1 pharmacological profile;
- to be exposed to the initiation of anxiolytic/hypnotic treatment within the week before the study or to be exposed to a change in the daily dosage of such an ongoing anxiolytic/hypnotic treatment within the week prior to the study due to its potential sedative properties in relation with its GABAergic activity;
- to be exposed to an antipsychotic treatment within the week prior to the study due to its potential sedative and orexigenic properties related to its anti-H1 pharmacological profile;
- to be exposed to alcohol consumption within 2 days before the study
- to have a body mass index <18.5 or ≥ 30;
- to undergo involuntary hospitalization;
- to be a pregnant, parturient or nursing women;
- to be a subject deprived of its liberty by judicial or administrative decision
- to be a subject under the safeguard measures; and,
- to be a subject undergoing an exclusion period for another clinical research
- Healthy volunteer group
- to have a previous history of somatic disorders, including neurological disease;
- to experience serious visual disturbances affecting the visual perception of colors;
- to be exposed to alcohol consumption within 2 days before the study
- to have a body mass index <18.5 or ≥ 25;
- to undergo involuntary hospitalization;
- to be a pregnant, parturient or nursing women;
- to be a subject deprived of its liberty by judicial or administrative decision
- to be a subject under the safeguard measures; and,
- to be a subject undergoing an exclusion period for another clinical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of an Innovative and Easy-to-use Tool Based on the Perception of Visual Food Stimuli for Assessing Hedonic and Motivational States in Major Depression.
Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with major depression, ii) compare their responses with healthy volunteers. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of depressed patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy.
Read the detailed description
Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. Several methodological approaches have been used to study hedonic and motivational processes in major depression. Some clinical investigations have tried to explore: i) taste sensitivity, as reflective of hedonic reaction to food stimuli, and ii) time judgment, as indicative of the degree of motivation, which is expected to be low when time is perceived long. However, these studies suffer from serious limitations relied on the frequent utilization of subjective assessment methods. Other authors have instead examined either: i) the processing of emotional information using positive, negative, and neutral faces or words, or ii) the processing of the motivational value of reinforcement, such as monetary cues. These experimental paradigms when coupled with functional neuroimaging allow objectively identifying the anatomo-functional correlates of the internal affective state. However, limited availability and costly procedures characterize the use of functional neuroimaging. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective, implicit and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D) (1). Both tasks are registered under the French agency for the protection of computer software. Here, the investigators propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from major depression ii) compare their responses with healthy volunteers. Responses to the test in depressed patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.
The present study is expected to begin in February 2017 for a total duration of 36 consecutive months. A sample of 36 patients suffering from major depression will be recruited and compared with 36 healthy normal volunteers. They will be matched on age and sex. During the inclusion visit, information about the study design will be delivered before the written inform consent is collected. Thereafter, the subjects will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" (AMDP) questionnaire, the Mini-International Neuropsychiatric Interview and the Three-Factor Eating Questionnaire for the anamnestic, diagnostic and psychometric (eating behavior) evaluations, respectively. Dietary habits will be recorded with a specific and appropriate instrument used in the National Program Nutrition Health.This will be associated to the assessment of: i) depressive and anxiety symptom.
severity with the Montgomery and Asberg Depression Rating Scale, the Brief Anxiety Scale, and overall functioning with the Global Assessment of Functioning scale in depressed patients; and, ii) neuropsychological functions including cognitive flexibility/psychomotor speed with the Trail making Test (A-B) and visuospatial memory with the Rey-Osterreich Figure Test. To ensure that subjects are familiar with the experimental procedure, the tasks A and B will be explained and the first 5-10 trials will be performed. Two separate experimental sessions will then be conducted, one in satiety and the other after a 6-hour fasting from the breakfast, 3-4 days apart. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Visual analogue scales (VAS) assessing hunger levels will be completed before each task is performed. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session. This procedure is adopted to avoid giving to the subject specific information about the exact objectives of the study and therefore to potentially limit biased responses to food images.
- Conditions
- Major Depression
- Being tested
- Computer-based tasks
- Keywords
- motivation, instrumental tasks, food-related stimuli, size/time discrimination, major depression
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based tasksBehavioural
Computer-based tasks designed to assess size and time discrimination capacities of food and control images
| Study group | Role | What they receive |
|---|---|---|
| Depressed patients | Experimental | Computer-based tasks evaluating size and time discrimination capacities of food and control images Receives: Behavioral: Computer-based tasks |
| Normal Healthy Volunteers | Experimental | Computer-based tasks evaluating size and time discrimination capacities of food and control images Receives: Behavioral: Computer-based tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point of subjective equality (PSE)
Change in the Point of subjective equality (PSE). The PSE is defined as the ratio "F"/"D" or "C"/"D" for which the stimulus "F" or "C" was judged greater than "D" with a probability of 0.5
Measured: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Secondary outcomes (1)
Percentage of subjective discrimination (PSD)
Change in the Percentage of subjective discrimination (PSD). The PSD is defined as the percentage of responses where the stimulus "F" or "C" was judged greater than "D" during the trials where the stimulus "F" or "C" was physically equal to "D", in terms of size or duration of presentation.
Measured: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start19 Sep 2017
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060967
- Sponsor's protocol ID
- C15-88
- Other IDs
- C15-88
- Acronym
- MOODDIS
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2017
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Innovative and Easy-to-use Tool Based on the Perception of Visual Food Stimuli for Assessing Hedonic and Motivational States in Major Depression.
- ClinicalTrials.gov ID
- NCT03060967
- Acronym / sponsor ID
- MOODDIS / C15-88
- Conditions
- Major Depression
- Keywords
- motivation, instrumental tasks, food-related stimuli, size/time discrimination, major depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures) and its devalued counterpart (food pictures in greyscale), at each trial, assessing either the size (task A) or the duration of presentation (task B). From these considerations, the present project aims at using our novel tool to: i) assess the hedonic and motivational state in subjects with major depression, ii) compare their responses with healthy volunteers. The present project should demonstrate that the behavioral tests validated in our laboratory are relevant experimental tools for the diagnostic/clinical assessment and for the phenotypic characterization of depressed patients. The application of the test in the therapeutic context could add further information about the efficacy and relevance of the chosen therapy.
Detailed description
Major depression is a frequent psychiatric disorder with an estimated lifetime prevalence of 16-17% in the general population. Although its pathophysiology is not completely understood, a large body of literature pleads for a causative role of disturbances in reward processes, referring to: i) the hedonic sensation (i.e. "liking") defined by the pleasure felt after exposure to appetitive stimuli, and ii) the motivation (i.e. "wanting") represented by the ability to initiate and maintain behavioral responses oriented toward appetitive stimuli. Several methodological approaches have been used to study hedonic and motivational processes in major depression. Some clinical investigations have tried to explore: i) taste sensitivity, as reflective of hedonic reaction to food stimuli, and ii) time judgment, as indicative of the degree of motivation, which is expected to be low when time is perceived long. However, these studies suffer from serious limitations relied on the frequent utilization of subjective assessment methods. Other authors have instead examined either: i) the processing of emotional information using positive, negative, and neutral faces or words, or ii) the processing of the motivational value of reinforcement, such as monetary cues. These experimental paradigms when coupled with functional neuroimaging allow objectively identifying the anatomo-functional correlates of the internal affective state. However, limited availability and costly procedures characterize the use of functional neuroimaging. the investigators have therefore developed and tested a new experimental computer-based and easy-to-use test intended to provide an objective, implicit and quantitative measurement of both hedonic and motivational states in humans. According to the task, the subjects are asked to view and to compare two stimuli, an appetitive one (food pictures; F) and its devalued counterpart (food pictures in greyscale; D), at each trial, assessing either the size (task A) or the duration of presentation (task B). Geometric figures are used as controls and presented in color (C) or greyscale (D) (1). Both tasks are registered under the French agency for the protection of computer software. Here, the investigators propose to use our novel test to: i) assess the hedonic and motivational state in subjects suffering from major depression ii) compare their responses with healthy volunteers. Responses to the test in depressed patients will be evaluated during two separate experimental sessions under either fasting or satiety conditions.
The present study is expected to begin in February 2017 for a total duration of 36 consecutive months. A sample of 36 patients suffering from major depression will be recruited and compared with 36 healthy normal volunteers. They will be matched on age and sex. During the inclusion visit, information about the study design will be delivered before the written inform consent is collected. Thereafter, the subjects will be screened using the "Association pour la Méthodologie et la Documentation en Psychiatrie" (AMDP) questionnaire, the Mini-International Neuropsychiatric Interview and the Three-Factor Eating Questionnaire for the anamnestic, diagnostic and psychometric (eating behavior) evaluations, respectively. Dietary habits will be recorded with a specific and appropriate instrument used in the National Program Nutrition Health.This will be associated to the assessment of: i) depressive and anxiety symptom.
severity with the Montgomery and Asberg Depression Rating Scale, the Brief Anxiety Scale, and overall functioning with the Global Assessment of Functioning scale in depressed patients; and, ii) neuropsychological functions including cognitive flexibility/psychomotor speed with the Trail making Test (A-B) and visuospatial memory with the Rey-Osterreich Figure Test. To ensure that subjects are familiar with the experimental procedure, the tasks A and B will be explained and the first 5-10 trials will be performed. Two separate experimental sessions will then be conducted, one in satiety and the other after a 6-hour fasting from the breakfast, 3-4 days apart. During each session, the participants will be asked to perform the two validated instrumental tasks in front the screen of a computer. Visual analogue scales (VAS) assessing hunger levels will be completed before each task is performed. A VAS will be also used for the global assessment of appetitive properties of the viewed food images just before the end of the second experimental session. This procedure is adopted to avoid giving to the subject specific information about the exact objectives of the study and therefore to potentially limit biased responses to food images.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed patients | Experimental | Behavioral: Computer-based tasksComputer-based tasks evaluating size and time discrimination capacities of food and control images |
| Normal Healthy Volunteers | Experimental | Behavioral: Computer-based tasksComputer-based tasks evaluating size and time discrimination capacities of food and control images |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Depressed patient group
- Healthy volunteer group
- to be between 20- and 60-year-old;
- to be free from any history of psychiatric disorder (substance abuse or alcohol abuse, dependence, mood disorders, etc.) that may require the prescription of long-term psychotropic treatment;
- to understand and accept the experimental procedure and constraints of the study;
Key exclusion criteria (26 listed)
- Depressed patient group
- Healthy volunteer group
- to have a previous history of somatic disorders, including neurological disease;
- to experience serious visual disturbances affecting the visual perception of colors;
- to be exposed to alcohol consumption within 2 days before the study
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 |
|---|---|---|
| Computer-based tasksComputer-based tasks designed to assess size and time discrimination capacities of food and control images | Behavioural | Depressed patients, Normal Healthy Volunteers |
Primary outcome
Point of subjective equality (PSE)
Time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Change in the Point of subjective equality (PSE). The PSE is defined as the ratio "F"/"D" or "C"/"D" for which the stimulus "F" or "C" was judged greater than "D" with a probability of 0.5
1 secondary outcome
Percentage of subjective discrimination (PSD)
Time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based tasks in people with Major Depression, run by Institut National de la Santé Et de la Recherche Médicale, France 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 12 inclusion and 26 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: withdrawn, as of the sponsor's last update on 25 Feb 2026. 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 withdrawn before enrolling participants, so there are no results.
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?
Point of subjective equality (PSE) (time frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)). 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 25 Feb 2026.