Last reviewed · How we verify
NCT06018298: ITAL-EE-REMS
Evaluation of Excellence in Italy's Residence for Execution of Security Measure
trial testing Treatment as usual (TAU) in Mental Disorder in 245 participants. Completed in 3 December 2022.
3 December 2022
Quick facts
| Lead sponsor | University of Bari |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 245 |
| Start date | 1 July 2018 |
| Primary completion | 3 December 2022 |
| Estimated completion | 3 December 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Treatment as usual (TAU) — full drug profile →
Conditions studied
- Mental Disorder — all drugs for Mental Disorder →
- Recovery — all drugs for Recovery →
- Schizophrenia and Related Disorders — all drugs for Schizophrenia and Related Disorders →
- Personality Disorders and Disturbances in Behavior — all drugs for Personality Disorders and Disturbances in Behavior →
Sponsor
University of Bari
Who can join
18 and older, any sex, with Mental Disorder or Recovery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed and new secure community residences for the execution of security measures (REMS) were opened in each of the 20 regions of Italy. This transition was in place by 2015. This observational study evaluates the health gains for patients both previously in OPGs and those admitted first to REMS. Health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Italian Evaluation and Excellence in REMS (ITAL-EE-REMS): appropriate placement of forensic patients in REMS forensic facilities.
Parente L, Carabellese F, Felthous A, La Tegola D, et al · · 2024 · cited 3× · PMID 39488677 · DOI 10.1186/s13033-024-00647-5 -
Italian Evaluation and Excellence in REMS (ITAL-EE-REMS): Appropriate placement of forensic patients in REMS forensic facilities
Parente L, Carabellese F, Felthous A, Tegola DL, et al · · 2023 · DOI 10.21203/rs.3.rs-3459344/v1
Verify or expand the search:
- PubMed search for NCT06018298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Treatment as usual (TAU)
Trials testing the same drug.
- NCT07345117 — Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Commun · NA · not yet recruiting
- NCT07386223 — Health and Lifestyle Support for Functional Hypothalamic Amenorrhea · NA · not yet recruiting
- NCT07384273 — Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression · NA · recruiting
- NCT07341438 — Physical Activity in the Management of Personality Disorders · NA · recruiting
- NCT07303608 — Improving Outcomes in Social Services Through Routine Outcome Monitoring and Systematic Client Feedback · NA · recruiting
Other recruiting trials for Mental Disorder
Currently open trials in the same condition.
- NCT07010614 — Brain Stimulation to the Hippocampus in Schizophrenia · NA · recruiting
- NCT06929533 — Pharmacogenomics-Supported Psychotropic Prescribing Trial · NA · recruiting
- NCT06813066 — Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence · NA · active not recruiting
- NCT06376734 — Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness · Phase 2 · recruiting
- NCT06625437 — ACT for HIV-Positive Men · NA · recruiting
Other University of Bari trials
Trials by the same sponsor.
- NCT06854133 — Factors of Effectiveness in Italian Forensic Treatment · not yet recruiting
- NCT07125625 — Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome · NA · not yet recruiting
- NCT07036627 — Intestinal Microbiota After PPI Treatment · not yet recruiting
- NCT07050693 — Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections. · NA · recruiting
- NCT06719999 — PRIMA Project- Box for Heath and Tradition (B4HT) · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06018298 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bari
- Last refreshed: 6 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06018298.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing