12 completed, 7 not yet recruiting, 7 recruiting, 7 unknown. 25 Not applicable, 2 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 25 | Completed 9, Recruiting 6, Not yet recruiting 5, Unknown 3, Active not recruiting 2 |
| Phase 2 | 2 | Unknown 2 |
| Phase 4 | 1 | Unknown 1 |
Follow Severe Mental Illness: new trials by email Literature Review of Severe Mental Illness trials Research Report on Severe Mental Illness
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) Semaglutide (SEMA), Exercise module, Anti-inflammatory diet module - Severe Mental Illness, Depression / Major Depressive Disorder | Not applicable | Not yet recruiting | Ludwig-Maximilians - University of Munich | 140 | 2028-10-01 | 2026-05-14 |
| Supporting Older Adults Remotely Supporting Older Adults Remotely (SOAR), Peer support as usual - Severe Mental Illness | Not applicable | Not yet recruiting | Dartmouth-Hitchcock Medical Center | 60 | 2026-12-01 | 2026-10-21 |
| A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness MoodSync, Standard care - Severe Mental Illness, Bipolar Disorder | Not applicable | Not yet recruiting | Alexandria University | 60 | 2026-11-01 | 2026-10-16 |
| Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness Severe Mental Illness, Hospitalizations Psychiatric | Not yet recruiting | Yale University | 25 | 2026-10-04 | 2026-10-21 | |
| Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness Occupational Therapy Group Intervention - Schizophenia Disorder, Severe Mental Illness | Not applicable | Not yet recruiting | Biruni University | 50 | 2026-10-01 | 2026-10-16 |
| Outcome of Patients With Severe Mental Illness in the Intensive Care Unit Observational follow-up - Severe Mental Illness, Severe Mental Disorder | Not yet recruiting | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | 2000 | 2026-09-01 | 2026-07-16 | |
| Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care Care Coordination Mobile - Severe Mental Illness | Not applicable | Recruiting | VA Office of Research and Development | 400 | 2026-08-10 | 2026-08-19 |
| Use of AI Chatbots for Mental Health Severe Mental Illness | Enrolling by invitation | Medizinische Hochschule Brandenburg Theodor Fontane | 150 | 2026-07-31 | 2026-10-08 | |
| A Study to Investigate Health Related Quality of Life With a Pharmacist Intervention Compared to Treatment as Usual in Participants With Severe Mental Illness and Substance Use Disorder Receiving Treatment From FACT Teams. Clinical Pharmacist Intervention - Severe Mental Illness, Substance Use Disorder (SUD) | Not applicable | Not yet recruiting | Sykehuset Innlandet HF | 160 | 2026-05-01 | 2026-05-19 |
| Ultra-Processed Foods, DASH Diet, and Well-Being in Severe Mental Illness No intervention (observational study) - Severe Mental Illness | Completed | Abant Izzet Baysal University | 105 | 2026-04-01 | 2026-09-28 | |
| Musical Intervention for the Management of Anxiety and Stress in People With Severe Mental Disorder in a Medium-stay Unit. Combined music therapy intervention (active and receptive) - Severe Mental Disorder, Severe Mental Illness | Not applicable | Active not recruiting | Alejando Vargas Rubio | 12 | 2026-03-03 | 2026-03-13 |
| Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES) Mental Health Recovery Star (MHRS) - Severe Mental Disorder, Severe Mental Illness | Not applicable | Recruiting | IRCCS Centro San Giovanni di Dio Fatebenefratelli | 72 | 2026-01-15 | 2025-12-18 |
| Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics Physical Exercise - Psychotic Disorders, Schizophrenia Spectrum Disorders (SSD) | Not applicable | Recruiting | University of Trás-os-Montes and Alto Douro | 44 | 2026-01-01 | 2026-04-29 |
| Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness À deux, c'est mieux (Better Together) Group Intervention - Severe Mental Illness, Schizophrenia | Not applicable | Recruiting | Centre hospitalier de Ville-Evrard, France | 20 | 2025-11-03 | 2026-01-05 |
| Norwegian Mental Illness Heart Health Study Lifestyle Intervention - Cardio Vascular Disease, Metabolic Syndrome (MetS) | Not applicable | Recruiting | Madeleine Elisabeth Angelsen | 70 | 2025-09-16 | 2025-10-02 |
| "Pilot Study of Music Intervention for Recovery of People With Severe Mental Disorder in the Community" Passive music therapy in an individual format - Severe Mental Disorder, Severe Mental Illness | Not applicable | Completed | Alejando Vargas Rubio | 12 | 2025-02-03 | 2026-02-02 |
| Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project Severe Mental Illness, Schizophrenia Spectrum &Amp; Other Psychotic Disorders | Recruiting | Bjorn H. Ebdrup | 75 | 2025-01-01 | 2026-05-04 | |
| Effectiveness of Mentalization-based Therapy (MBT) Mentalisation-Based Therapy, Treatment as Usual (TAU) - Severe Mental Illness | Not applicable | Recruiting | Oulu University Hospital | 128 | 2024-09-25 | 2025-04-25 |
| Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) Cognitive remediation + active tDCS, Cognitive remediation + sham tDCS - Severe Mental Illness | Not applicable | Active not recruiting | University of Groningen | 126 | 2024-05-06 | 2026-06-26 |
| Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections This research doesn't involve any kind of intervention on the study participants - Severe Mental Illness, Inflammation | Active not recruiting | Sara Poletti | 408551 | 2024-05-02 | 2025-05-14 |
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Mental Disorders (37) · Schizophrenia (10) · Bipolar Disorder (9) · Motor Activity (5) · Psychotic Disorders (5) · Depressive Disorder, Major (3) · Anxiety Disorders (2) · Cardiovascular Diseases (2) · Depression (2) · Empowerment (2) · Medication Adherence (2) · Mood Disorders (2) · Social Adjustment (2) · Emotional Regulation (1) · Frailty (1)
Behavior (17) · Schizophrenia Spectrum and Other Psychotic Disorders (12) · Bipolar and Related Disorders (9) · Mood Disorders (8) · Social Behavior (5) · Behavioral Symptoms (3) · Depressive Disorder (3) · Health Behavior (3) · Treatment Adherence and Compliance (3) · Chemically-Induced Disorders (2) · Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2) · Patient Acceptance of Health Care (2) · Patient Compliance (2) · Glucose Metabolism Disorders (1)
Exercise (4) · Therapeutics (2) · Cognitive Remediation (1) · Community Mental Health Services (1) · Exergaming (1) · Immunization, Secondary (1) · Observation (1) · Salvage Therapy (1) · Standard of Care (1) · semaglutide (1)
Shalvata Mental Health Center (3) · Alejando Vargas Rubio (2) · Dartmouth-Hitchcock Medical Center (2) · Abant Izzet Baysal University (1) · Alexandria University (1) · Biruni University (1) · Bjorn H. Ebdrup (1) · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (1) · Centre hospitalier de Ville-Evrard, France (1) · Consorci Hospitalari de Vic (1) · Education University of Hong Kong (1) · GGZ Centraal (1) · IRCCS Centro San Giovanni di Dio Fatebenefratelli (1) · Indiana University (1) · King's College London (1)
United States (7) · Israel (4) · Netherlands (4) · Spain (4) · Norway (3) · France (2) · Germany (2) · Italy (2) · Turkey (Türkiye) (2) · Austria (1) · Bahrain (1) · Belgium (1) · Denmark (1) · Finland (1) · Hong Kong (1)
Alessandra Martinelli, MD PhD (1) · Alexander Stehle Young, MD MSHS (1) · Anne Signe Landheim (1) · Daniel T Bressington, PhD (1) · Gary Morse, PhD (1) · Kristin Kosyluk (1) · Lisette van der Meer, PhD (1)
PMID 25897762, PMID 26932324, PMID 27863522, PMID 30030938, PMID 30711868, PMID 31438960, PMID 36905736, PMID 37940915, PMID 39543515, PMID 40691811, PMID 41769638, PMID 42132738
R56MH138734 (1), R61MH144505 (1)