Predicting Transitions From Depression to Wellbeing Through a Network-based Operationalization of Plasticity
A legfontosabb adatok
- Ki végzi
- IRCCS San Raffaele
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 200 fő, tervezett
- Kezdés
- 2026. nov.
- Várható befejezés
- 2029. nov.
- A vizsgálat típusa
- Megfigyeléses
- A vizsgált kezelések
- Clinical and cognitive assessments
- Multimodal MRI
- Blood sampling for multi-omic analyses
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
- Életkor
- 18 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 9 feltétel megnézéseKevesebb
Ki vehet részt
- OSR will recruit 200 people who meet all these inclusion criteria:
- Is willing and able to give informed consent for participation in the study
- Aged 18-70
- Diagnosed with nonpsychotic Major Depressive Disorder according to DSM-5 criteria
- 14 or higher on the 17-Hamilton Depression Rating Scale (HDRS)
Ki nem vehet részt
- Diagnosed with bipolar disorder, schizophrenia, psychosis NOS; anorexia or bulimia nervosa; OCD
- Presents a medical condition not compatible with the protocol
- Considering the 200 MDD patients' sample OSR will recruit, an individual who meets any of the following criteria will be excluded from participation in this study:
- Is pregnant or breast feeding
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 70 év között vagy?
A vizsgálatról
Mit akar kideríteni a vizsgálat
Major depressive disorder (MDD) is one of the leading causes of disability worldwide, and many patients do not respond adequately to available treatments. Plasticity, the ability of the brain and mind to change, is thought to be a crucial process in the transition from depression to wellbeing, but methods to measure it are limited. The Network Theory of Plasticity proposes that the weaker the connections among the elements of a system (for example, the symptoms of a patient or the regions of the brain), the higher its plasticity. Earlier analyses of large clinical datasets (STAR*D and CO-MED) supported this idea at the population level.
A teljes eredeti leírásKevesebb
PlastNet is an observational study that aims to validate this approach at the individual level. Two hundred adults (18-70 years) with nonpsychotic MDD recruited at IRCCS Ospedale San Raffaele will undergo resting-state brain MRI, blood sampling and clinical assessments at baseline, and clinical assessments again after four weeks. No treatment is assigned by the study.
The investigators hypothesize that lower baseline functional connectivity in the brain is associated with a greater reduction in depressive symptoms over four weeks. The study will also investigate whether blood-based multi-omic profiles (genomic, transcriptomic and metabolomic) can identify biological signatures of plasticity. The results could help clinicians tailor treatments to each patient's level of plasticity.
A vizsgálat csoportja
- MDD cohort
200 adult outpatients and inpatients (aged 18-70 years) recruited at IRCCS Ospedale San Raffaele, Milan, with a DSM-5 diagnosis of nonpsychotic major depressive disorder (MDD) and a score of 14 or higher on the 17-item Hamilton Depression Rating Scale (HDRS). Exclusion criteria are bipolar disorder, schizophrenia, psychosis NOS, anorexia or bulimia nervosa, OBCD, medical conditions incompatible with the protocol, and pregnancy or breastfeeding. At baseline, participants undergo structural and resting-state functional MRI, clinical and cognitive assessments, and blood sampling for multi-omic analyses. Clinical and cognitive assessments are repeated at 4 weeks. No intervention is assigned by the study; participants continue their usual care.
Kezelés: Clinical and cognitive assessments, Multimodal MRI és Blood sampling for multi-omic analyses
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Illeszkedési kérdések
- Forrás: NCT07933276: ki vehet részt
- A regiszteradat frissítve
- 2026. november 12.