Recruiting

Characterization of High-Level Cognitive Impairments in Patients With Neuropsychiatric Disorders

ClinicalTrials.gov IDNCT07295652

PhaseNA

Enrollment600

SponsorCentre Hospitalier St Anne

Age18 Years

SexALL

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Conditions studied

Neurologic Disorders, Schizophrenia, Bipolar Disorder (BD), Depressive Disorder

About this study

Neuropsychiatric disorders are extremely common, severe, and disabling conditions. In the field of psychiatry, they notably include schizophrenia, mood disorders (depressive and bipolar disorders), autism spectrum or neurodevelopmental disorders, obsessive-compulsive disorder, eating disorders, and personality disorders. In the field of neurology, one can cite neurodegenerative diseases (such as Alzheimer's disease, but also frontotemporal dementia or Parkinson's disease, which often represent frequent and challenging differential diagnoses of psychiatric disorders), focal neurological lesions (notably strokes and tumors), or epilepsy. Cognitive impairments are present in nearly all neuropsychiatric disorders and contribute significantly to disability. While impairments in working memory and attention, executive functions, and social cognition have been relatively well studied, other cognitive domains remain largely unexplored in these populations. This is particularly the case for various aspects of motivation, metacognition, conscious access, or causal (Bayesian) inference. Although these domains likely play an important role in prognosis, no consensus currently exists regarding the methods for evaluating these functions. The main objective of this study is to define a multidimensional, transdiagnostic atlas of high-level cognitive impairments-both specific and shared-across severe psychiatric disorders (notably schizophrenia, depressive disorder, bipolar disorder, autism spectrum or neurodevelopmental disorders, and obsessive-compulsive disorder) and neurological disorders (notably neurodegenerative diseases, focal neurological lesions, and epilepsy), by comparing them to healthy volunteers. The investigators also aim to investigate the progression of cognitive impairments over time, across different phases of illness (symptom stabilization or exacerbation) or therapeutic intervention, through longitudinal follow-up of patients being monitored within the recruiting center. Finally, in a more exploratory manner, the investigators aim to investigate the neural correlates of the identified cognitive impairments.

Interventions

Behavioral: Cognitive assessment — This intervention consists of computerized neuropsychological assessments designed to evaluate high-level cognitive impairments. The tests cover various cognitive dimensions including motivation, metacognition, conscious access, and Bayesian causal inference. These assessments are performed using computers or tablets, aiming to build a multidimensional cognitive atlas comparing patients with severe psychiatric and neurological conditions to healthy volunteers. The tests will be progressively optimized for usability and adapted to the specific difficulties faced by patients. For some participants, additional brain imaging (MRI without contrast, EEG, MEG) may be offered optionally to identify neural correlates of cognitive deficits.
Behavioral: Brain MRI (optional) — Brain MRI without contrast perform at one visit to identify neural correlates of cognitive deficits
Behavioral: Electroencephalography (optional) — Electroencephalography performed at one visit
Behavioral: Magnetoencephalography (optional) — Magnetoencephalography performed at one visit

Primary outcomes

Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains (Baseline, and up to one year after baseline)

Eligibility information

Inclusion Criteria: For patients: * Aged over 18 years * Diagnosed with a psychiatric disorder according to ICD-10 by a psychiatrist (F10-F98) or diagnosed with a neurological disorder according to ICD-10 by a neurologist (G00-G99) * Provided written informed consent * Affiliated with a social security scheme For healthy volunteers: * Aged over 18 years * Provided written informed consent * Affiliated with a social security scheme Exclusion Criteria: For healthy volunteers: * Current diagnosis of a psychiatric disorder according to ICD-10 (F20-F98) or current prescription of a psychotropic medication, or diagnosis of a neurological disorder according to ICD-10 (G00-G99) * History of depression (F32) * Substance use disorder (excluding tobacco) * Neurological history (e.g., stroke, coma, epilepsy, neuroinflammatory or neurodegenerative disease) or identified cognitive disorder * Inability to complete cognitive testing (e.g., due to motor or sensory impairment) For participants undergoing MRI (without contrast agent): * Presence of MRI contraindications: non-MRI-compatible pacemaker, heart valve, implant, or metallic foreign body * Pregnancy at the time of MRI

Study locations

Departement of Adult Psychiatry, GH Pitié Salpétrière, Paris, 75013 France
Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences, Paris, 75014 France
Hôpital Fondation Adolphe de Rothschild, Paris, France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.