Status:

NOT_YET_RECRUITING

A Biological Signature for the Early Differential Diagnosis of Psychosis

Lead Sponsor:

IRCCS San Raffaele

Collaborating Sponsors:

Ministry of Health, Italy

Conditions:

Schizophrenia

Bipolar Disorder

Eligibility:

All Genders

18-65 years

Brief Summary

Schizophrenia (SZ) and mood disorders (BD, MDD) are among the most disabling disorders worldwide, with a relevant social, functional, and economic burden. Although they are identified as distinct diso...

Eligibility Criteria

Inclusion

  • Aged 18-65
  • diagnosed with Schizophrenia, Bipolar Disorder or Major depressive disorder.
  • For Bipolar and Major depressive disorder, Hamilton Depression Rating Scale scores \>8
  • Multimodal 3 T MRI acquisition available (\*)
  • Genetic and serum inflammatory data available, or serum and whole blood available for genotyping and inflammatory markers determination.

Exclusion

  • Presence of major medical or neurological disorders
  • Alcohol or drugs abuse or dependence
  • Conditions known to alter immune-inflammatory status, such as rheumatic diseases, malignancies,
  • ongoing treatment with drugs acting on the immune system, such as corticosteroids, NSAIDs and other immunomodulatory drugs.
  • Pregnancy or lactating

Key Trial Info

Start Date :

August 31 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

1850 Patients enrolled

Trial Details

Trial ID

NCT06515522

Start Date

August 31 2024

End Date

August 1 2026

Last Update

July 23 2024

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