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NCT06071858
Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
NA trial testing Care Coordination in Psychosis in 350 participants. Currently enrolling.
1 October 2028
Quick facts
| Lead sponsor | Mclean Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 1 February 2024 |
| Primary completion | 1 October 2028 |
| Estimated completion | 1 October 2028 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Care Coordination
- Individual Peer Support
- Digital Outreach
- Cognitive Remediation — full drug profile →
- Multi-Family Group Therapy
Conditions studied
- Psychosis — all drugs for Psychosis →
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
- Psychosis Nos/Other — all drugs for Psychosis Nos/Other →
Sponsor
Mclean Hospital
Who can join
Eligibility, any sex, with Psychosis or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Months Engaged in Care
Time frame: 12 months following clinic intake
Number of months each participant had ≥4 visits in a 12-month period
Sponsor's own description
The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is: • Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either: * Receive care as usual (CSC) or * Receive care as usual (CSC) plus five additional care elements (CSC 2.0): 1. Individual peer support 2. Digital outreach 3. Care coordination 4. Multi-family group therapy 5. Cognitive remediation Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Changes in first-episode psychosis care delivery and outcomes throughout the COVID-19 pandemic: Insights from a learning healthcare system in Massachusetts.
Saluja A, Johnson KA, Öngür D, Lanca M, et al · · 2025 · cited 2× · PMID 40300255 · DOI 10.1016/j.schres.2025.04.010
Verify or expand the search:
- PubMed search for NCT06071858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT04182906 — Pediatric ACEs Screening and Resiliency Study · NA · completed
Other recruiting trials for Psychosis
Currently open trials in the same condition.
- NCT07213492 — Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder · NA · recruiting
- NCT07056894 — Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
- NCT07196462 — Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia · NA · recruiting
- NCT07364825 — Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care · NA · recruiting
Other Mclean Hospital trials
Trials by the same sponsor.
- NCT07519759 — Recovery Inspired Support Engagement (RISE) Pilot · NA · not yet recruiting
- NCT07503093 — Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis · NA · not yet recruiting
- NCT07503067 — Identifying Substance Use Consequences · recruiting
- NCT06816329 — Stress Dynamics and Familial Risk for Depression in Female Adolescents · NA · recruiting
- NCT06876129 — Pharmacologic Augmentation of TMS for Depression With D-serine · Phase 1 · 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 NCT06071858 (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 Mclean Hospital
- Last refreshed: 25 February 2026
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/NCT06071858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing