Investigating the Role of Negr1 in Depression Treatment

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

This study is testing if a protein called NEGR1 can help improve treatment for people with Major Depressive Disorder and Bipolar Disorder by looking at how it affects their brain and body after taking a medication for four weeks.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (other)
• Locations: 1 site (Milan, MI)
• Trial ID: NCT06131268 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the role of the NEGR1 protein in modulating neuroplasticity among patients with Major Depressive Disorder (MDD) and Bipolar Affective Disorder experiencing a depressive episode. Patients will be assessed at baseline and after 4 weeks of treatment with venlafaxine, using psychometric and functional scales to measure clinical response. Additionally, neuroimaging and blood samples will be collected to analyze the expression of ncRNA and other biomarkers related to depression. The study aims to identify potential biological markers that could enhance treatment outcomes for these conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals recently diagnosed with Major Depressive Disorder or Bipolar Disorder currently experiencing a depressive episode.

Not a fit: Patients currently on venlafaxine or those with a history of severe suicidal behavior may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with major depression and bipolar disorder.

How similar studies have performed: While the specific approach of examining NEGR1 in this context may be novel, similar studies have shown promise in identifying biomarkers for depression treatment.

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

Where this trial is running

Milan, MI

• Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico — Milan, MI, Italy (RECRUITING)

Study contacts

• Principal investigator: Giandomenico Schiena, Doctor — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study coordinator: Giandomenico Schiena, Doctor

Conditions: Major Depressive Disorder, Bipolar Affective Disorder, Currently Depressed, Moderate, major depressive disorder, NEGR1 protein, antidepressants, venlafaxina, NEGR1 mRna, brain connectivity