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

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ClinicalTrials.gov Identifier: NCT03060967
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Computer-based tasks Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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.
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depressed patients
Computer-based tasks evaluating size and time discrimination capacities of food and control images
Behavioral: Computer-based tasks
Computer-based tasks designed to assess size and time discrimination capacities of food and control images

Experimental: Normal Healthy Volunteers
Computer-based tasks evaluating size and time discrimination capacities of food and control images
Behavioral: Computer-based tasks
Computer-based tasks designed to assess size and time discrimination capacities of food and control images




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of subjective discrimination (PSD) [ Time Frame: From fasting to satiety conditions 3 days apart (days 4 and 7 after inclusion) ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Depressed patient group

    1. to be between 20- and 60-year-old;
    2. to meet the DSM-5 diagnostic criteria for major depressive disorder;
    3. 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);
    4. to understand and accept the experimental procedure and constraints of the present study;
    5. to give written consent for the participation to the study; and,
    6. to be a beneficiary of or affiliated to a health insurance plan.

Healthy volunteer group

  1. to be between 20- and 60-year-old;
  2. 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;
  3. 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

Exclusion Criteria:

  • Depressed patient group

    1. 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;
    2. to experience serious visual disturbances affecting the visual perception of colors;
    3. 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;
    4. 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);
    5. 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;
    6. 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;
    7. 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;
    8. 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;
    9. to be exposed to alcohol consumption within 2 days before the study
    10. to have a body mass index <18.5 or ≥ 30;
    11. to undergo involuntary hospitalization;
    12. to be a pregnant, parturient or nursing women;
    13. to be a subject deprived of its liberty by judicial or administrative decision
    14. to be a subject under the safeguard measures; and,
    15. to be a subject undergoing an exclusion period for another clinical research

Healthy volunteer group

  1. to have a previous history of somatic disorders, including neurological disease;
  2. to experience serious visual disturbances affecting the visual perception of colors;
  3. to be exposed to alcohol consumption within 2 days before the study
  4. to have a body mass index <18.5 or ≥ 25;
  5. to undergo involuntary hospitalization;
  6. to be a pregnant, parturient or nursing women;
  7. to be a subject deprived of its liberty by judicial or administrative decision
  8. to be a subject under the safeguard measures; and,
  9. to be a subject undergoing an exclusion period for another clinical research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060967


Contacts
Contact: Bruno Aouizerate, Professor of Psychiatry 05 56 56 17 98 bruno.aouizerate@u-bordeaux.fr
Contact: Didier Delhaye, Psychiatric physician pro.delhaye@gmail.com

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03060967     History of Changes
Other Study ID Numbers: C15-88
C15-88 ( Other Identifier: Institut National de la Santé Et de la Recherche Médicale )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
motivation, instrumental tasks, food-related stimuli, size/time discrimination, major depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders