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Disease

Psychotic disorder

Late-stage therapeutic development

Also known as psychosis, mental or behavioral disorder, mental or behavioural disorder.

24
Clinical trials
12
Associated genes
6
Related proteins
Current focus
5-hydroxytryptamine 2a biologyD(2) dopamine biologyTherapeutic development

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q4 2026.
  • 12 industry developments reported.
Upcoming Milestones
Clinical Milestones11View all 11
Results expected 5
Recently completed 3
Other updates 2
+3 more in the activity timeline below
Industry & Market12View all 12
+7 more in the activity timeline below
Activity timeline23

Clinical trials

18 sponsors · 2 new · 3 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Phase 3 · Recruiting · Intra-Cellular Therapies, Inc.

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Phase 3 · Recruiting · Neurocrine Biosciences

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis

Phase 4 · Recruiting · Northwell Health

Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum

Phase 4 · Recruiting · Deepak K. Sarpal, M.D.

PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "

Phase 3 · Recruiting · Centre Hospitalier St Anne

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 52-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications

Phase 3 · Recruiting · Minerva Neurosciences
Recruiting

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Phase 3 · Recruiting · Intra-Cellular Therapies, Inc.

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Phase 3 · Recruiting · Neurocrine Biosciences

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis

Phase 4 · Recruiting · Northwell Health

Neural Mechanisms of Anticholinergic Burden in Mid- to Late-Life Schizophrenia Spectrum

Phase 4 · Recruiting · Deepak K. Sarpal, M.D.

PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "

Phase 3 · Recruiting · Centre Hospitalier St Anne

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 52-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications

Phase 3 · Recruiting · Minerva Neurosciences
Recently completed

The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled Trial

Phase 3 · Completed · Central South University

An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Phase 3 · Completed · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease

Phase 3 · Completed · Tasly Pharmaceutical Group Co., Ltd

Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder

Phase 3 · Completed · BioXcel Therapeutics Inc

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia: A Randomized, Group Sequential Adaptive Design, Controlled Clinical Trial

Phase 4 · Completed · All India Institute of Medical Sciences, Bhubaneswar

Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study

Phase 2/3 · Completed · The University of Hong Kong

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

DRD20.62HTR2A0.61HTR2C0.60DRD30.60DRD40.59HTR1A0.59HTR2B0.48PIDD10.46HTR60.39DRD10.39HTR1B0.39HTR5A0.39

Disease biology

6 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

D(2) dopamine receptorvia DRD20.625-hydroxytryptamine receptor 2Avia HTR2A0.615-hydroxytryptamine receptor 2Cvia HTR2C0.60D(3) dopamine receptorvia DRD30.60D(4) dopamine receptorvia DRD40.595-hydroxytryptamine receptor 1Avia HTR1A0.59

Reference

Authoritative identity, definition & identifiers.

Synonyms

psychosis, mental or behavioral disorder, mental or behavioural disorder

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.