Psychiatric DisorderMEOPNCT07406113
MEOP - Multidimensional Evaluations in Oncological Psychiatry
An observational study of Psychiatric Disorder and Cognition Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Cognition Disorder, Treatment Compliance
- What is being tested?
- Psychiatric and neuropsychological evaluation through rating scales
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 29 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The Clinical and Emergency Psychiatry Unit and provides outpatient psychiatric assessments and consultations in inpatients wards and day hospitals of the aforementioned institution. Subjects will undergo a first psychiatric evaluation by a clinician of the aforementioned unit. Then, the subject will be assigned to one of the study groups (see above).
Who may be able to join
- For cases: any subject affected by cancer with a comorbid psychiatric disorder (further defined as "cases") or any first-degree relative of a subject of a "case" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder). These first-degree relatives will be defined as "cases-rel".
- For controls: a) Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms (further defined as "oncology-controls"); b) subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms (further defined as "psy-controls"); c) Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation (further defined as "healthy controls"); d) First-degree relatives of "oncology-controls", "psy-controls" and "healthy controls" (further defined as "control-rel").
- Age between 18 and 75 years.
- Capability of providing written informed consent.
Who cannot join
- Severe cognitive impairment or inability to provide written informed consent.
- Severe unstable neurological disorders, such as traumatic brain injury, Alzheimer's Disease or dementia.
- Inability to perform psychiatric or neuropsychological evaluations.
About this study
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes.
The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss.
Read more
Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.
Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.
Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.
Read the detailed description
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level. While considerable advances have been made in understanding and treating the biological aspects of cancer, its psychological and psychiatric impacts remain a major concern. Psychiatric disorders, including depression, anxiety, post-traumatic stress disorder (PTSD), and adjustment disorders, are frequently observed in cancer patients. These disorders are not only common but also underdiagnosed, as their symptoms are often misinterpreted as normal emotional reactions to the illness. This misperception undermines the recognition of significant psychiatric conditions that require targeted interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. For instance, stress and depression can directly affect tumour biology through neuroendocrine and immune mechanisms, including increased inflammatory responses and dysregulated cortisol levels, via the chronic activation of the Hypothalamic-Pituitary-Adrenal axis (HPA). Indirectly, psychiatric symptoms can impair treatment adherence and lead to lifestyle choices that increase the risk of recurrence, such as poor nutrition, lack of physical activity, or substance use.
The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, dysregulation of biology in cancer patients might confer greater vulnerability to psychiatric disorders. The production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines, including IL-6, TNF-α, CRP, and IL-1ra. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss. Since tumour-related inflammation emerges early in the progression of cancer, depression and other psychological symptoms might manifest as initial indicators of the disease.
Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.
Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.
Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients is crucial. However, there are several difficulties in assessing these patients. First, there is a need to better understand the psychopathology behind cancer. Frequently, symptoms like depression and anxiety are conceived as normal reactions to cancer, whereas cancer can trigger severe syndromes, which are frequently overlooked. Second, studies related to common biological patterns linking cancer and psychiatric disorders are poorly investigated. Furthermore, there is a lack of studies that assess the effectiveness and safety of pharmacological and non-pharmacological treatments in these patients.
Family members of cancer patients experience significant emotional and psychological strain, yet their psychiatric symptoms are often overlooked. The biological underpinnings of these symptoms in caregivers, as well as effective treatments tailored to this population, are under-researched. Addressing the mental health needs of families is essential to improving overall care outcomes in oncology.
This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.
- Conditions
- Psychiatric Disorder, Cognition Disorder, Treatment Compliance, Adverse Drug Event, Family Members
- Being tested
- Psychiatric and neuropsychological evaluation through rating scales
- Medical subject headings
- Mental Disorders, Cognition Disorders, Patient Compliance, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric and neuropsychological evaluation through rating scalesBehavioural
Also called Medical evaluation and blood testing.
Psychiatric evaluation: a) assessment of previous psychiatric history and family history; b) assessment of the presence of a psychiatric syndrome;c) evaluation of mental status; d) evaluation and documentation of psychopharmacological and psychotherapeutic treatments assumed; e) documentation of any side effects related to treatment.
Administration of psychiatric rating scales. Clinical evaluation: a) collection of medical history; b) recording of chemo- or radiotherapy assumed and current pharmacological treatments; c) physical examination.
Blood samples Neuropsychological evaluation that will include a series of tests investigating different neurocognitive domains.
| Study group | Role | What they receive |
|---|---|---|
| Cases | any subject affected by cancer with a comorbid psychiatric disorder Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales | |
| cases-rel | any first-degree relative of a subject of a "case" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales | |
| oncology-controls | Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales | |
| psy-controls | subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales | |
| healthy controls | Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales | |
| control-rel | First-degree relatives of "oncology-controls", "psy-controls" and "healthy controls" Receives: Behavioral: Psychiatric and neuropsychological evaluation through rating scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric differences
Evaluate psychiatric differences among cases and controls over the time
Measured: January 2026 - January 2035
Secondary outcomes (10)
Demographic characteristics course over time
Evaluate differences of certain demographical characteristics among cases and controls over time
Measured: January 2026 - January 2035
Medical characteristics course over time
Evaluate presence/absence of certain medical characteristics among cases and controls over time
Measured: January 2026 - January 2035
Biological characteristics course over time
Evaluate presence/absence of certain biological characteristics among cases and controls over time
Measured: January 2026 - January 2035
Neuropsychological characteristics course over time
Evaluate presence/absence of certain neuropsychological characteristics among cases and controls over time
Measured: January 2026 - January 2035
Differences in psychiatric symptoms in subjects under different medications
Evaluate differences in presence/absence of certain psychiatric symptoms among subjects under certain medications and their course over time
Measured: January 2026 - January 2035
Differences in psychiatric rating scales in subjects under different medications
Evaluate differences in scores of psychiatric rating scales among subjects under certain medications and their course over time
Measured: January 2026 - January 2035
Differences in biological characteristics and their course over time
Evaluate differences among cases and controls over time in levels of C-reactive protein, erythrocyte sedimentation rate, interleukines, vitamin D, folate, vitamin B12, iron, ferritin, transferrin, total iron-binding capacity, glucose, insulin, glycated hemoglobin, triglycerides, cholesterol , apolipoproteins, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, bilirubin, glomerular filtration rate, uric acid, sodium, potassium, chloride, calcium, magnesium, phosphorus, cortisol, adrenocorticotropic hormone, prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen, white blood cell count, red blood cell count, hemoglobin, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, neutrophil-to-lymphocyte ratio, and albumin and prealbumin levels.
Measured: January 2026 - January 2035
Biological differences in subjects under different medications
Evaluate differences and their course over time of the following biological parameters: C-reactive protein, erythrocyte sedimentation rate, interleukines, vitamin D, folate, vitamin B12, iron, ferritin, transferrin, total iron-binding capacity, glucose, insulin, glycated hemoglobin, triglycerides, cholesterol , apolipoproteins, transaminases, alkaline phosphatase, bilirubin, glomerular filtration rate, uric acid, sodium, potassium, chloride, calcium, magnesium, phosphorus, cortisol, adrenocorticotropic hormone, prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen, white blood cell count, red blood cell count, hemoglobin, platelet count, neutrophil-to-lymphocyte ratio, and albumin and prealbumin levels.
Comparisons will be made in subjects undergoing different medicatiosns such as antidepressants, mood stabilizers, antipsychotics, benzodiazepines, stimulants.
Measured: January 2026 - January 2035
Side effects
Compare rates of side effects related to different classes of pharmacological treatments.
Measured: January 2026 - January 2035
Correlations between biology and neuropsychology and illness burden
Correlate alterations of neuropsychology and biological markers (inflammatory cytokines and blood cells count,) with severity of psychiatric symptoms at T0 and the evolution of these relationships over time.
Measured: January 2026 - January 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion29 Jan 2036 (estimated)
- Study completion29 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406113
- Sponsor's protocol ID
- 7944
- Acronym
- MEOP
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEOP - Multidimensional Evaluations in Oncological Psychiatry
- ClinicalTrials.gov ID
- NCT07406113
- Acronym / sponsor ID
- MEOP / 7944
- Conditions
- Psychiatric Disorder, Cognition Disorder, Treatment Compliance, Adverse Drug Event, Family Members
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 29 Jan 2036 (estimated)
- Study completion
- 29 Jan 2036 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes.
The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss.
Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.
Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.
Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.
Detailed description
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level. While considerable advances have been made in understanding and treating the biological aspects of cancer, its psychological and psychiatric impacts remain a major concern. Psychiatric disorders, including depression, anxiety, post-traumatic stress disorder (PTSD), and adjustment disorders, are frequently observed in cancer patients. These disorders are not only common but also underdiagnosed, as their symptoms are often misinterpreted as normal emotional reactions to the illness. This misperception undermines the recognition of significant psychiatric conditions that require targeted interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. For instance, stress and depression can directly affect tumour biology through neuroendocrine and immune mechanisms, including increased inflammatory responses and dysregulated cortisol levels, via the chronic activation of the Hypothalamic-Pituitary-Adrenal axis (HPA). Indirectly, psychiatric symptoms can impair treatment adherence and lead to lifestyle choices that increase the risk of recurrence, such as poor nutrition, lack of physical activity, or substance use.
The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, dysregulation of biology in cancer patients might confer greater vulnerability to psychiatric disorders. The production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines, including IL-6, TNF-α, CRP, and IL-1ra. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss. Since tumour-related inflammation emerges early in the progression of cancer, depression and other psychological symptoms might manifest as initial indicators of the disease.
Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.
Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.
Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients is crucial. However, there are several difficulties in assessing these patients. First, there is a need to better understand the psychopathology behind cancer. Frequently, symptoms like depression and anxiety are conceived as normal reactions to cancer, whereas cancer can trigger severe syndromes, which are frequently overlooked. Second, studies related to common biological patterns linking cancer and psychiatric disorders are poorly investigated. Furthermore, there is a lack of studies that assess the effectiveness and safety of pharmacological and non-pharmacological treatments in these patients.
Family members of cancer patients experience significant emotional and psychological strain, yet their psychiatric symptoms are often overlooked. The biological underpinnings of these symptoms in caregivers, as well as effective treatments tailored to this population, are under-researched. Addressing the mental health needs of families is essential to improving overall care outcomes in oncology.
This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalesany subject affected by cancer with a comorbid psychiatric disorder |
| cases-rel | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalesany first-degree relative of a subject of a "case" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder |
| oncology-controls | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalesSubjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms |
| psy-controls | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalessubjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms |
| healthy controls | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalesSubjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation |
| control-rel | – | Behavioral: Psychiatric and neuropsychological evaluation through rating scalesFirst-degree relatives of "oncology-controls", "psy-controls" and "healthy controls" |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The Clinical and Emergency Psychiatry Unit and provides outpatient psychiatric assessments and consultations in inpatients wards and day hospitals of the aforementioned institution. Subjects will undergo a first psychiatric evaluation by a clinician of the aforementioned unit. Then, the subject will be assigned to one of the study groups (see above).
Key inclusion criteria (4 listed)
- For cases: any subject affected by cancer with a comorbid psychiatric disorder (further defined as "cases") or any first-degree relative of a subject of a "case" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder). These first-degree relatives will be defined as "cases-rel".
- For controls: a) Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms (further defined as "oncology-controls"); b) subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms (further defined as "psy-controls"); c) Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation (further defined as "healthy controls"); d) First-degree relatives of "oncology-controls", "psy-controls" and "healthy controls" (further defined as "control-rel").
- Age between 18 and 75 years.
- Capability of providing written informed consent.
Key exclusion criteria (3 listed)
- Severe cognitive impairment or inability to provide written informed consent.
- Severe unstable neurological disorders, such as traumatic brain injury, Alzheimer's Disease or dementia.
- Inability to perform psychiatric or neuropsychological evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric and neuropsychological evaluation through rating scalesAlso: Medical evaluation and blood testing.Psychiatric evaluation: a) assessment of previous psychiatric history and family history; b) assessment of the presence of a psychiatric syndrome;c) evaluation of mental status; d) evaluation and documentation of psychopharmacological and psychotherapeutic treatments assumed; e) documentation of any side effects related to treatment. Administration of psychiatric rating scales. Clinical evaluation: a) collection of medical history; b) recording of chemo- or radiotherapy assumed and current pharmacological treatments; c) physical examination. Blood samples Neuropsychological evaluation that will include a series of tests investigating different neurocognitive domains. | Behavioural | Cases, cases-rel, control-rel, healthy controls, oncology-controls, psy-controls |
Primary outcome
Psychiatric differences
Time frame: January 2026 - January 2035
Evaluate psychiatric differences among cases and controls over the time
10 secondary outcomes
Demographic characteristics course over time
Time frame: January 2026 - January 2035
Medical characteristics course over time
Time frame: January 2026 - January 2035
Biological characteristics course over time
Time frame: January 2026 - January 2035
Neuropsychological characteristics course over time
Time frame: January 2026 - January 2035
Differences in psychiatric symptoms in subjects under different medications
Time frame: January 2026 - January 2035
Differences in psychiatric rating scales in subjects under different medications
Time frame: January 2026 - January 2035
Differences in biological characteristics and their course over time
Time frame: January 2026 - January 2035
Biological differences in subjects under different medications
Time frame: January 2026 - January 2035
Side effects
Time frame: January 2026 - January 2035
Correlations between biology and neuropsychology and illness burden
Time frame: January 2026 - January 2035
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Cognition Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric differences (time frame: January 2026 - January 2035). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.