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:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06131268
Eligibility Criteria:
Inclusion Criteria:
* GRUPPO 1: Recently diagnosed MDD, ongoing depressive episode, as determined by SCID-CV;
* Clinical indication to switch from current antidepressant therapy to venlafaxine due to lack of efficacy and/or tolerance and/or compliance.
GRUPPO 2: Recent diagnosis of BD with a current depressive episode, as determined by SCID-CV;
\- absence of antidepressants in the patient's drug regimen.
GRUPPO 3: No diagnosis of psychiatric disorders made as a result of SCID-CV.
Exclusion Criteria:
* GRUPPO 1: - treatment with venlafaxine ongoing or within 6 months before the recruitment
* concomitant treatment with an irreversible MonoAmine Oxidase Inhibitor (I-MAO) or interruption of the IMAO treatment before 14 days from the recruitment;
* pregnant and breastfeeding woman;
* Lifetime comorbidity for psychotic disorders, as determined by the SCID-CV;
* Lifetime or recent history of suicide attempts or suicide-related behaviors and ideation (lifetime and/or recent C-SSRS Ideation or Behavior sub-score \>0);
* Current, clinically meaningful, substance use disorders;
* Current comorbidity with neurological conditions or severe head trauma; -Neuropsychological diagnosis of intellectual disability;
* Presence of contraindications to lumbar puncture or MRI
* known hypersensitivity to the active substance venlafaxine or to any of the excipients
* Women of Childbearing Potential without a negative pregnancy test and not undertaking a high effective anticonception treatment at the recruitment
GRUPPO 2:
* Lifetime comorbidity for psychotic disorders, as determined by the SCID-CV;
* Current, clinically meaningful, substance use disorders;
* Current comorbidity with neurological conditions or severe head trauma;
* Neuropsychological diagnosis of intellectual disability;
* Presence of contraindications to lumbar puncture or MRI.
GRUPPO 3:
* Current or previous lifetime therapy with antidepressants
* Current, clinically meaningful, substance use disorders;
* Current comorbidity with neurological conditions or severe head trauma;
* Neuropsychological diagnosis of intellectual disability;
* Presence of contraindications to MRI scan
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06131268
Study Brief:
Protocol Section:
NCT06131268