The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN)

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 evaluate clinical and functional response to treatment. MDD patients will be screened for the lifetime and recent occurrence of clinically meaningful suicidal ideation and behavior prior to recruitment (-T1). Moreover, in the MDD group, the emergence of clinically meaningful suicidal ideation and behavior will be evaluated at the baseline (T0) and after 4 weeks (T1) by means of the C-SSRS, accordingly to the routine clinical practice. Furtherly, to accomplish the pursues of this research, the two groups will undergo neuroimaging evaluation and a blood collection at the two timepoints for measuring the expression of ncRNA before and after treatment. Meanwhile, a lumbar puncture (LP) for CSF collection will be carried out at the baseline, measuring central levels of Negr-1 and other biomarkers of neurotropism potentially related to the aforementioned role of Negr1 in MDD. Group 3 will be comprehensive of 10 subjects without current or previous diagnosis of psychiatric disorders (healthy controls), who will be evaluated at baseline with psychometric and functional scales, neuroimaging and blood samples collection for ncRNA. Data obtained by the multimodal assessment of HCs at the baseline will be employed as normalization features in the statistical analysis of patients' data.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Treatments: Venlafaxine Hydrochloride

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