Major Depressive DisorderDepTypeNCT05816018
Improving Health Care in Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 30,900 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2021to 15 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients with an ongoing depressive episodes diagnosed accordingly to DSM 5.
Who may be able to join
- diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
- at least one depressive episode preceding the current one;
- aged between 18 and 65;
- score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
- signature of the information form and declaration of informed consent;
- elementary school certificate (as a minimum requirement for understanding the questions presented in the tests);
- native Italian speaker (or bilingualism).
Who cannot join
- diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
- diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
- disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
- pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Irene Bollettini, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Benedetta Vai
Milan, 20131
Benedetta Vai, PhD, +393335652025, vai.benedetta@hsr.it
About this study
Official title: Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures
This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).
- Conditions
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
The depressive status
Assessment of the severity of disease using the Self-report Inventory Of Depressive Symptoms (IDS-SR) (Rush et al., 1996) with minimum-maximum values 0-116, higher scores mean a worse outcome, regarding the last week.
Measured: Assessment at the time of recruitment
The self-report depressive symptomatology
Assessment of the depressive characteristics, using the Beck Depression Inventory (BDI) (Beck et al., 1961) with minimum-maximum values 0-39, higher scores mean a worse outcome, regarding the last 2 weeks.
Measured: Assessment at the time of recruitment
The clinical evaluation of depressive symptomatology
Assessment of the presence of depressive status, Hamilton Depression Rating Scale (HDRS) (Hamilton, 1967) with minimum-maximum values 0-69, higher scores mean a worse outcome, regarding the current state.
Measured: Assessment at the time of recruitment
The rate of cardiovascular and/or cardiometabolic diseases
Assessment of the presence/absence of lifetime and current cardiometabolic and/or cardiovascular diseases (e.g. diabetes, arterial hypertension, pulmonary arterial hypertension) based on extracted data from medical records and chart.
Measured: Assessment at the time of recruitment
Secondary outcomes (1)
The quality of functioning and well-being
Assessment of current and lifetime quality of life and well-being using the WHO Quality of Life-BREF (WHOQOL-BREF) (World Health Organization, 1996): the minimum and maximum values are 0-118, higher scores mean a better outcome, regarding the last 2 weeks.
Measured: Assessment at the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Oct 2021
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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
- Cohort
- Time perspective
- Other
- Enrolment
- 30,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Principal investigator, Benedetta Vai, Ospedale San Raffaele
- Investigators
- Benedetta Vai, PhD, Principal investigator, IRCCS San Raffaele Scientific Insititute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816018
- Sponsor's protocol ID
- GR-2019-12370616
- Acronym
- DepType
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Colombo F, Calesella F, Bravi B, Fortaner-Uya L, Monopoli C, Tassi E, Carminati M, Zanardi R, Bollettini I, Poletti S, Lorenzi C, Spadini S, Brambilla P, Serretti A, Maggioni E, Fabbri C, Benedetti F, Vai B. Multimodal brain-derived subtypes of Major depressive disorder differentiate patients for anergic symptoms, immune-inflammatory markers, history of childhood trauma and treatment-resistance. Eur Neuropsychopharmacol. 2024 Aug;85:45-57. doi: 10.1016/j.euroneuro.2024.05.015. Epub 2024 Jun 26.
PubMed 38936143
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Care in Major Depressive Disorder: a New Prognostic Tool Based on Gene Environment and Neuroimaging Signatures
- ClinicalTrials.gov ID
- NCT05816018
- Acronym / sponsor ID
- DepType / GR-2019-12370616
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,900 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 18 Apr 2023 (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.
This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients with an ongoing depressive episodes diagnosed accordingly to DSM 5.
Key inclusion criteria (7 listed)
- diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
- at least one depressive episode preceding the current one;
- aged between 18 and 65;
- score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
- signature of the information form and declaration of informed consent;
Key exclusion criteria (4 listed)
- diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
- diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
- disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
- pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The depressive status
Time frame: Assessment at the time of recruitment
Assessment of the severity of disease using the Self-report Inventory Of Depressive Symptoms (IDS-SR) (Rush et al., 1996) with minimum-maximum values 0-116, higher scores mean a worse outcome, regarding the last week.
The self-report depressive symptomatology
Time frame: Assessment at the time of recruitment
Assessment of the depressive characteristics, using the Beck Depression Inventory (BDI) (Beck et al., 1961) with minimum-maximum values 0-39, higher scores mean a worse outcome, regarding the last 2 weeks.
The clinical evaluation of depressive symptomatology
Time frame: Assessment at the time of recruitment
Assessment of the presence of depressive status, Hamilton Depression Rating Scale (HDRS) (Hamilton, 1967) with minimum-maximum values 0-69, higher scores mean a worse outcome, regarding the current state.
The rate of cardiovascular and/or cardiometabolic diseases
Time frame: Assessment at the time of recruitment
Assessment of the presence/absence of lifetime and current cardiometabolic and/or cardiovascular diseases (e.g. diabetes, arterial hypertension, pulmonary arterial hypertension) based on extracted data from medical records and chart.
1 secondary outcome
The quality of functioning and well-being
Time frame: Assessment at the time of recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 38936143Colombo F, Calesella F, Bravi B, Fortaner-Uya L, Monopoli C, Tassi E, Carminati M, Zanardi R, Bollettini I, Poletti S, Lorenzi C, Spadini S, Brambilla P, Serretti A, Maggioni E, Fabbri C, Benedetti F, Vai B. Multimodal brain-derived subtypes of Major depressive disorder differentiate patients for anergic symptoms, immune-inflammatory markers, history of childhood trauma and treatment-resistance. Eur Neuropsychopharmacol. 2024 Aug;85:45-57. doi: 10.1016/j.euroneuro.2024.05.015. Epub 2024 Jun 26.
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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. This study is not recruiting at the moment.
Irene Bollettini, PhD contact
Benedetta Vai, PhD principal investigator
IRCCS San Raffaele Scientific Insititute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Ospedale San Raffaele at 1 site in Italy.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetta Vai, PhD (+393335652025, vai.benedetta@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The depressive status (time frame: Assessment at the time of recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816018, which also lists 1 linked publication.
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 18 Apr 2023.