28 completed, 5 unknown, 3 active not recruiting, 3 recruiting. 22 Not applicable, 7 Phase 4, 6 Phase 3, 3 Phase 2, 1 Early Phase 1.
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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 |
|---|---|---|---|---|---|---|
| Shared Decision Making for Antipsychotic Medications The Antipsychotic Medication Decision Aid (APM-DA) - Schizophrenia, Schizoaffective Disorder | Not applicable | Not yet recruiting | New York State Psychiatric Institute | 120 | 2027-01-01 | 2026-03-30 |
| REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health) Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness, Usual Community-Based Mental Health Care - Schizophrenia, Schizo Affective Disorder | Not applicable | Recruiting | Case Western Reserve University | 30 | 2026-08-30 | 2026-08-17 |
| Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder BXCL501 Sublingual Film - Bipolar I Disorder, Bipolar II Disorder | Phase 2 | Completed | BioXcel Therapeutics Inc | 33 | 2025-06-19 | 2026-10-05 |
| Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia Individual Placement and Support, Cognitive Remediation Therapy - Schizophrenia, Schizophreniform Disorders | Not applicable | Unknown | Pakistan Institute of Living and Learning | 120 | 2024-12-01 | 2024-05-17 |
| Young Adults With Violent Behavior During Early Psychosis (Aim 2) adapted behavioral intervention - Schizophrenia, Schizo Affective Disorder | Not applicable | Completed | Columbia University | 12 | 2024-03-19 | 2026-10-05 |
| Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography PET Scan - Schizophrenia, Schizophreniform Disorders | Active not recruiting | Centre for Addiction and Mental Health | 58 | 2024-03-11 | 2025-03-28 | |
| REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention Rewritalize, Standard mental health care - Schizophreniform Disorders, Bipolar Disorder | Not applicable | Active not recruiting | Amager Hospital | 300 | 2024-02-12 | 2026-02-04 |
| Horyzons: Implementation and Integration in Clinical Practice Horyzons USA - Schizophrenia, Schizophreniform Disorders | Not applicable | Terminated | University of North Carolina, Chapel Hill | 52 | 2024-01-08 | 2025-09-18 |
| iTBS to Enhance Social Cognition in People With Psychosis iTBS (Active), iTBS (Sham) - Schizophrenia, Schizo Affective Disorder | Not applicable | Recruiting | Northwell Health | 100 | 2023-10-30 | 2026-10-08 |
| Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder Sublingual film containing Igalmi - Bipolar Disorder, Schizophrenia | Phase 4 | Completed | BioXcel Therapeutics Inc | 29 | 2023-10-02 | 2026-08-11 |
| Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department Sublingual film containing dexmedetomidine (BXCL501) - Agitation, Schizophrenia | Phase 4 | Withdrawn | Brigham and Women's Hospital | 2023-09-01 | 2026-01-28 | |
| EPI-MINN: Targeting Cognition and Motivation - National Cognitive and Social Cognitive Training, Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App, Early Psychosis Coordinated Specialty Care - Psychosis, Psychosis Nos/Other | Not applicable | Active not recruiting | University of Minnesota | 55 | 2023-05-30 | 2026-07-10 |
| Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) BXCL501, Matching Placebo - Agitation,Psychomotor, Bipolar I Disorder | Phase 3 | Completed | BioXcel Therapeutics Inc | 452 | 2022-11-21 | 2026-08-07 |
| Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders Cognitive Remediation (REHACOP), Metacognitive Training (MCT) - Schizophrenia, Schizophreniform Disorders | Not applicable | Unknown | Universitat Autonoma de Barcelona | 160 | 2022-09-01 | 2024-05-23 |
| Remote State Representation in Early Psychosis BrainHQ Computerized Cognitive Training - Visual Perception Training Paradigm, BrainHQ Computerized Cognitive Training - Visual Cognitive Control Training Paradigm - Psychosis, Schizophrenia | Early Phase 1 | Completed | University of Minnesota | 152 | 2022-07-27 | 2025-10-03 |
| Academic-Community EPINET (AC-EPINET) Coordinated Specialty Care (CSC) - Schizophrenia, Schizoaffective Disorder | Not applicable | Completed | Indiana University | 74 | 2022-03-16 | 2025-12-24 |
| Peripheral Immune System in Individuals With Schizophrenia SCID (Standardized Clinical Interview for DSM-V), PSS (Perceived Stress Score), Urine Toxicology Screen - Schizophrenia, Schizo Affective Disorder | Completed | Stanford University | 63 | 2021-03-01 | 2025-06-06 | |
| Horyzons: Implementation in Clinical Practice Horyzons USA - Schizophrenia, Schizoaffective Disorder | Not applicable | Completed | University of North Carolina, Chapel Hill | 85 | 2021-01-19 | 2024-08-15 |
| Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders Repetitive Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation), Repetitive Transcranial Magnetic Stimulation (Sham) - Schizophrenia, Schizoaffective Disorder | Not applicable | Completed | Centre for Addiction and Mental Health | 70 | 2020-11-30 | 2023-10-17 |
| ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention Active SMS Intervention, Sham SMS - First Episode Psychosis, Psychosis | Not applicable | Completed | Centre for Addiction and Mental Health | 186 | 2020-09-21 | 2026-03-18 |
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Psychotic Disorders (43) · Schizophrenia (40) · Bipolar Disorder (8) · Psychomotor Agitation (5) · Schizophrenia Spectrum and Other Psychotic Disorders (5) · Schizophrenia, Paranoid (4) · Affective Disorders, Psychotic (3) · Inflammation (2) · Mental Disorders (2) · Schizotypal Personality Disorder (2) · Aggression (1) · Borderline Personality Disorder (1) · Delusions (1) · Depression (1) · Diabetes Mellitus (1)
Mental Disorders (41) · Schizophrenia Spectrum and Other Psychotic Disorders (38) · Behavior (11) · Behavioral Symptoms (8) · Bipolar and Related Disorders (8) · Mood Disorders (8) · Pathological Conditions, Signs and Symptoms (8) · Aberrant Motor Behavior in Dementia (6) · Nervous System Diseases (6) · Neurobehavioral Manifestations (6) · Neurologic Manifestations (6) · Signs and Symptoms (6) · Dyskinesias (5) · Psychomotor Disorders (5) · Personality Disorders (3)
Dexmedetomidine (4) · Estradiol (2) · Olanzapine (2) · Risperidone (2) · Therapeutics (2) · Acetylcysteine (1) · Amyloid (1) · Cognitive Remediation (1) · Gene Expression (1) · Lorazepam (1) · Magnetic Resonance Spectroscopy (1) · PRIME protocol (1) · Paliperidone Palmitate (1) · Palliative Care (1) · Pravastatin (1)
Centre for Addiction and Mental Health (5) · BioXcel Therapeutics Inc (4) · University of Minnesota (4) · University of North Carolina, Chapel Hill (4) · Massachusetts General Hospital (2) · Pakistan Institute of Living and Learning (2) · Tangent Data (2) · Alkermes, Inc. (1) · Amager Hospital (1) · Bispebjerg Hospital (1) · Brigham and Women's Hospital (1) · Case Western Reserve University (1) · Chonbuk National University Hospital (1) · Columbia University (1) · Indiana University (1)
United States (22) · Canada (5) · Denmark (2) · Moldova (2) · South Korea (2) · Spain (2) · United Kingdom (2) · Australia (1) · Austria (1) · Germany (1) · Hong Kong (1) · Ireland (1) · Israel (1) · Italy (1) · Netherlands (1)
BioXcel MM (2) · BioXcel MM, MD (2) · David L Penn, PhD (2) · David Penn, PhD (2) · Diana Perkins, MD, MPH (2) · George Foussias, MD, PhD (2) · Sophia Vinogradov, MD (2) · Agnieszka Kalinowski, MD PhD (1) · Alan Breier (1) · Albert HC Wong, MD, PhD (1) · Ana Barajas Velez (1) · Anil Malhotra, MD (1) · Ariel Graff, MD, PhD (1) · Aristotle N Voineskos, MD, PhD (1)
PMID 42526755, PMID 10622350, PMID 11318766, PMID 11458304, PMID 12271808, PMID 1503131, PMID 15285956, PMID 15863743, PMID 16055815, PMID 16055817, PMID 16122909, PMID 16141449, PMID 18447961, PMID 2028808, PMID 22626057, PMID 23244442, PMID 2374885, PMID 25914107, PMID 26948484, PMID 28374661, PMID 31365044, PMID 32499262, PMID 33334839, PMID 36002761, PMID 36198061, PMID 36811902, PMID 36946605, PMID 37252256, PMID 37527479, PMID 37778356, PMID 38343378, PMID 39144112, PMID 39639282, PMID 40643782, PMID 42531158, PMID 447850, PMID 7726309, PMID 8532098, PMID 8783894, PMID 8817704, PMID 9000318, PMID 9707298
K23MH126312 (1), P50MH119569 (1), R01MH118634 (1), R01MH120588 (1), R01MH120589 (1), R33MH100250 (1), R34MH111852 (1)