The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN)
Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico