Assessment of Hedonic and Motivational States in Major Depression ( MOODDIS)

NCT03060967 | Withdrawn

• 1 other identifier: C15-88
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Major Depression

Keywords

motivation, instrumental tasks, food-related stimuli, size/time discrimination, major depression

Outcome Measures

Primary Outcomes (1)

• 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

  From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)

Secondary Outcomes (1)

• Percentage of subjective discrimination (PSD)

  From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion)

Study Arms (2)

Depressed patients

EXPERIMENTAL

Computer-based tasks evaluating size and time discrimination capacities of food and control images

Behavioral: Computer-based tasks

Normal Healthy Volunteers

EXPERIMENTAL

Computer-based tasks evaluating size and time discrimination capacities of food and control images

Behavioral: Computer-based tasks

Interventions

Computer-based tasks BEHAVIORAL

Computer-based tasks designed to assess size and time discrimination capacities of food and control images

Depressed patients; Normal Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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;
• \) to give written consent for the participation to the study; and, 4) to be a beneficiary of or affiliated to a health insurance plan

You may not qualify if:

• 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;
• 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,

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

NeuroCentre Magendie INSERM U862

Bordeaux, 33077 Bordeaux Cedex, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: September 19, 2017
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: February 25, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)