An observational study in Schizophrenia Disorders, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Observational
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Among 65 studies in Schizophrenia with a site in Italy — 7 open to participants now, 9 under way, none of them phase 3. Schizophrenia · Italy.
Among the 65 studies in Schizophrenia with a site in Italy, this one is the 16th largest by planned enrollment of the 18 observational ones that give a count, is one of 4 that started in 2024, is one of 18 observational ones, and was the 61st registered.
3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.
Browse Schizophrenia studies →7 of the 65 studies in Schizophrenia with a site in Italy are open now. Recruiting first, the newest first:
Dr. Inge Winter · Sites in Italy, Austria, Germany and 2 more countries
Ages 18–70
University of Udine · Sites in Italy
Ages 18–35
IRCCS San Camillo, Venezia, Italy · Sites in Italy
Ages 18+ · Healthy volunteers
Università degli Studi di Ferrara · Sites in Italy
Ages 18+
IRCCS San Raffaele · Sites in Italy
Ages 18–65 · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
65 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 75 is below the median of 178 across 507 observational studies indexed under Schizophrenia.
Median enrollment 300 across the 47 interventional studies, 273 across the 18 observational. Of the 51 that completed or were terminated, 21 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
40 of 65 have an industry lead sponsor. The 10 most frequent:
IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
IRCCS Centro San Giovanni di Dio Fatebenefratelli has 2 studies filed under Schizophrenia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 65 studies in Schizophrenia with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Schizophrenia (SCZ) is a severe neuropsychiatric disorder characterized by cognitive decline, social withdrawal, and positive symptoms such as hallucinations and delusions. Research suggests that SCZ and schizotypy exist along a continuum, with shared structural and behavioral abnormalities, the latter of which encompass the sensory and perceptual domain, often in the form of altered multisensory integration, as seen in tasks like the Sound-Induced Flash Illusion (SIFI). Individuals with schizotypal traits or SCZ show enlarged temporal binding windows (TBW) of cross-modal integration, affecting perceptual accuracy and multisensory judgments. However, whether these deficits stem from overactive top-down modulation or weakened bottom-up sensory precision remains unclear.
The current study seeks to address these questions, by asking participants (healthy individuals screened as for their schizotypal traits, and patients suffering from SCZ) to complete a modified version of the SIFI, as well as an audiovisual temporal order judgment (TOJ) task. Cross-modal performance will be assessed via signal detection theory (SDT) metrics and psychometric modeling to estimate individual TBWs, thereby assaying audiovisual processing abilities along the schizotypal continuum
Schizophrenia (SCZ) is among the most debilitating syndromes within the neuropsychiatric domain, with patients suffering from this condition displaying a rich nosographic characterization. Besides, anhedonia, social withdrawal, and a progressive cognitive decline, positive manifestations such as delusions and hallucinations are perhaps the hallmark symptomatological features underlying this disorder. Notably, prodromal stages that entail subclinical cognitive and/or psychotic symptoms have often been shown to anticipate SCZ onset, corroborating a dimensional approach toward the understanding of such psychiatric disorder. Indeed, it has been proposed that schizotypal traits exist within the general population and that schizotypy and SCZ may correspond to quantitative poles within the same continuum, with the former (i.e., individuals characterized with high schizotypal traits, HST) including subjects displaying many SCZ-related subthreshold clinical signs, and thus, more likely to develop the latter. However, no reliable biomarker to early detect such psychosis-prone individuals has been so far, leaving clinicians without pre-emptive policies toward risk mitigation.
It should be nonetheless highlighted that both demeaned microstructural and white matter integrity have been reported in schizotypy and SCZ alike, the magnitude of which predicting the severity of positive symptoms at the individual level. Given the pivotal role these neuroanatomical features play in relaying electrical signals across the brain, it is not surprising that SCZ patients, as well as HST individuals, oftentimes exhibit aberrant oscillatory dynamics within the low-frequency ranges, such as in the alpha band (7-13 Hz). These brain oscillations are the dominant rhythm in both the resting and active brain. As such, they have been found to subserve many functions closely tied to sensory processing. Among multifold operational features these rhythms appear to be endowed with, their occipital cycling speed (i.e., individual alpha frequency peak, also known as IAF) has been recently associated with the efficiency by which sensory information is integrated or segregated, according to the task at hand . In agreement with the discrete sampling hypothesis of perception, the faster (or slower) these rhythms oscillate, the higher (or lower) the observers' visual sampling rate and their perceptual or cognitive accuracy.
Of note, this electrocortical index bears trait-like features that have been shown to parametrize perceptual performance, especially in multisensory contexts.
For instance, the propensity to report an illusory percept in audiovisual tasks such as the Sound-Induced Flash Illusion (SIFI) was found to negatively correlate with the IAF as recorded from occipital loci: the slower the IAF, the greater the number of illusory percepts and vice-versa. These results align with pieces of research showing a critical contribution of alpha oscillatory speed when individuals are asked to perform cross-modal simultaneity judgments and visuo-tactile tasks as well. Intriguingly, evidence for a tie between the IAF and multisensory temporal binding windows (TBW) has been further reinvigorated by data showing slower IAFs in patients suffering from schizophrenia or displaying schizotypal traits. Namely, those clinical and subclinical populations performing poorly at the SIFI, and, more broadly, multisensory paradigms, due to enlarged TBWs.
As for the neurocomputational mechanics subsiding this intricate pattern of alterations, it remains a matter of debate whether they might be driven either by an over-exploitation of auditory-relayed priors, or poor bottom-up sensory processing. Indeed, although alterations in sensory integration/segregation are a core hallmark of SCZ, it is not entirely clear whether such behavioral and cognitive impairments might be due to defective sensory processing (i.e. poor sensory input due to reduced feedforward connectivity), or aberrant perceptual bias mechanisms (i.e. disproportionately high top-down signaling), and to which extent they may be present at prodromal stages of the disease. To this aim, we will therefore investigate the performance of SCZ patients, and individuals displaying either high (HST) or low (LST) schizotypal traits, in a series of tasks relying on multisensory interaction. We will do so by implementing signal detection theory (SDT) matched with logistic fitting, to clarify at a finer-grained level whether alterations in multisensory processes can be accounted for by deficits at the level of sensory input (d'), top-down control (c), or both.
Healthy participants assigned either to the low (LST) or high (HST) schizotypal group will be recruited from the general population, after being screened for their schizotypal traits via the Schizotypal Personality Questionnaire (SPQ, Raine, 1991). Individuals with SPQ scores falling within the first and last quintile of the overall SPQ scores distribution will then be recruited and assigned, respectively, to the LST and HST groups.
SCZ patients will be recruited via the Psychiatric Unit of IRCCS Centro San Giovanni di Dio Fatebenefratelli
Inclusion Criteria (all participants):
Inclusion Criteria (patients):
Exclusion Criteria (all participants):
Exclusion Criteria (patients)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with schizophrenia spectrum disorders
Other: Audio-Visual Perceptual Tasks
Healthy individuals displaying low schizotypal traits
Other: Audio-Visual Perceptual Tasks
Healthy individuals displaying high schizotypal traits
Other: Audio-Visual Perceptual Tasks
Around 75 participants will be recruited for this study (25 per each group), and asked to perform two distinct audiovisual tasks (run via Matlab-based automated routines, and presented using a CRT monitor and a pair of loudspeakers) : 1. TOJ task, in which a white flashing dot, and a basic auditory stimulus, will be presented in close temporal proximity at several stimulus onset asynchronies (SOAs, from 30 to 540 ms in steps of 30 ms), with participants asked to report ( after each trial), which stimulus occurred first (task duration estimate: 25 minutes, 30 trials per each SOA) 2. A modified version of the SIFI (mSIFI), in which the presentation of paired (and temporally close) auditory stimuli will be coupled with the occurrence of either 1 or 2 flashing dots, at several different SOAs (from 30 to 250 ms in steps of 10 ms), with participants asked to report (after each trial), whether they saw 1 vs 2 flashes (task duration estimate: 25 minutes, 30 trials per each SOA)
Temporal Binding Window (TBW) length
The temporal binding window (TBW) is a psychophysical construct that reflects an observer's tolerance for temporal asynchrony-a "window" of time within which multisensory stimuli are likely to be perceptually bound or integrated. As such, it serves as a proxy for cross-modal performance. In both tasks, individual TBWs will be estimated for each participant by fitting gaussian and sigmoidal logistic functions to error rates (i.e., inverse accuracy) and perceptual sensitivity metrics (i.e., d', as computed combining hits and flase alarms according to signal detection theory), respectively, across the asynchrony space (e.g., at each SOA). The width (e.g., standard deviation) of the gaussian function and the inflection point (e.g., midpoint) of the sigmoidal curve will be then derived on a participant-by-participant basis, serving as behavioral indices of TBW span (in milliseconds) for further statistical analyses and comparison between groups.
Time frame: Right after tasks completion
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Oct 2025, 18 months after the start.
Of 114 non-industry observational studies under Schizophrenia, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 114. This study's planned 18 months is below that.
Counting every sponsor, half of 136 studies reached it within 47 months; a quarter within 27 and three quarters within 102.
How these figures are worked out, and which studies are left out of them.
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IRCCS Centro San Giovanni di Dio Fatebenefratelli