Status:
UNKNOWN
The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN)
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Major Depressive Disorder
Bipolar Affective Disorder, Currently Depressed, Moderate
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Patients belonging to Group 1 (Major Depression) and 2 (Bipolar Disorder) will be tested with psychometric and functional scales at baseline (T0) and after 4 weeks of pharmacological therapy (T1), to ...
Detailed Description
In this clinical trial, the investigators will recruit a cohort consisting of 10 patients with MDD who will be evaluated at baseline (T0) and at 4 weeks from the setting of drug treatment with venlafa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06131268
Start Date
March 1 2022
End Date
April 1 2024
Last Update
November 14 2023
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, Italy, 20100