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Identifying and validating cognitive profiles in schizophrenia and bipolar disorder: prospective phase of the PerfilesMICEmiEZ-TB study

PerfilesMICEmiEZ-TB — Phase 2 Prospective Protocol: a multicenter de novo longitudinal cohort study to validate neurocognitive endophenotypes in schizophrenia and bipolar disorder using the MICEmi model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13022511
Enrollment
900
Registered
2026-04-30
Start date
2028-01-01
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, bipolar disorder Mental and Behavioural Disorders

Interventions

This is a prospective, observational, longitudinal de novo multicenter cohort study conducted across nine CIBERSAM research groups in eight Spanish National Health System centres in four autonomous co
2. Fasting peripheral blood sampling for: inflammatory cytokines (IL-6, IL-10, TNF-a) by multiplex xMAP/Luminex
neurotrophins (BDNF, NT-3) by ELISA
leukocyte-endothelial interaction in dynamic parallel-flow chamber
mitochondrial function and oxidative stress by fluorimetric techniques
and full metabolic profile (HbA1c, fasting glucose and insulin [HOMA index], lipid profile, microalbuminuria, hsCRP). 3. Physical frailty assessment using the Fried phenotype (unintentional weight los
supplemented by the 5-repetition Sit-to-Stand te

Sponsors

Centro de Investigación Biomédica en Red de Salud Mental
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged =18 years 2. Confirmed diagnosis of schizophrenia or bipolar disorder according to DSM-5-TR/ICD-11 (patient groups) 3. Unaffected first-degree relatives (parents, siblings or offspring) of individuals with schizophrenia or bipolar disorder (relative groups) 4. No personal or first-degree family history of mental disorder (healthy control group) 5. Written informed consent provided

Exclusion criteria

Exclusion criteria: 1. Major neurocognitive disorder or intellectual disability 2. Sensory or language barriers precluding cognitive assessment 3. For relative and healthy control groups: any lifetime diagnosis of a psychotic or major affective disorder

Countries

Spain

Contacts

Public ContactPatricia;Rafael Correa-Ghisays;Tabarés-Seisdedos

;

patricia.correa@uv.es;rafael.tabares@uv.es+34 (0)605216779;+34 (0)963864744

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026