Assessment of Hedonic and Motivational States in Major Depression ( MOODDIS)
Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Feb 17, 2017
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect 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. Several methodological approaches have been used...
Gender
ALL
Eligibility 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
About Institut National De La Santé Et De La Recherche Médicale, France
The Institut National de la Santé et de la Recherche Médicale (INSERM) is France's key public research organization dedicated to advancing knowledge in health and biomedical sciences. Established to foster innovation and improve public health outcomes, INSERM conducts a wide range of clinical trials and research initiatives aimed at translating scientific discoveries into effective medical treatments and interventions. With a focus on collaboration among researchers, healthcare professionals, and industry partners, INSERM plays a pivotal role in shaping health policies and enhancing the quality of care in France and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bordeaux, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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