Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT03060967
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03060967
Study Brief:
Protocol Section:
NCT03060967