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Disease
Mania
Late-stage therapeutic developmentEmerging research
1
Publications
24
Clinical trials
2024
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Adolescent Psychedelic Use and Psychotic or Manic Symptoms.
Research2024-06-01JAMA psychiatry
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
- 5 clinical trials expected to report results, the earliest in Q2 2027.
Upcoming Milestones
- Q2 2027A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
- Q2 2028A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
- Q4 2028RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
- Q4 2031A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
- Q2 2032An 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
Major developments
Upcoming trial readoutHigh impact
Results expected Q2 20322026-07-31
Upcoming trial readoutHigh impact
Results expected Q4 20312026-07-07
Clinical MilestonesViewHide
Results expected
- 2026-07-31An 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 DisorderResults expected Q2 2032
- 2026-07-07A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 YearsResults expected Q4 2031
- 2026-06-23A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineResults expected Q2 2027
- 2026-06-22RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)Results expected Q4 2028
- 2026-01-22A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.Results expected Q2 2028
Recently completed
- 2025-10-06A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum DisorderCompleted
- 2025-08-15Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar DisorderCompleted
Other updates
Activity timeline8
- 2027-05-01ClinicalDopamine D3 Receptor Occupancy in Bipolar Depression by Cariprazine (Vraylar): Evaluating Its Antidepressant BenefitWithdrawn
- 2026-07-31ClinicalAn 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 DisorderResults expected Q2 2032
- 2026-07-07ClinicalA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 YearsResults expected Q4 2031
- 2026-06-23ClinicalA Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineResults expected Q2 2027
- 2026-06-22ClinicalRNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)Results expected Q4 2028
- 2026-01-22ClinicalA Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.Results expected Q2 2028
- 2025-10-06ClinicalA 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum DisorderCompleted
- 2025-08-15ClinicalEfficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar DisorderCompleted
Clinical trials
The current development programme across all trial phases.
Clinical programme
24
6
18
6
Late-stage studies
Recruiting
Recently completed
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Most influential
Recent publications
Major themes2
- Hallucinogens1
- Registries1
Leading journals1
- JAMA psychiatry1
Leading researchers7
- Larsson H1
- Lu Y1
- Mosing MA1
- Osika W1
- Simonsson O1
- Ullén F1
- Wesseldijk LW1
Affiliations (unnormalised)5
- Amsterdam University Medical Center1
- Karolinska Institutet1
- Max Planck Institute for Empirical Aesthetics1
- Melbourne School of Psychological Sciences1
- School of Medical Sciences1
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
A state of elevated excitement with over-activity sometimes accompanied with psychotic symptoms (e.g., PSYCHOMOTOR AGITATION, inflated SELF ESTEEM and flight of ideas). It is often associated with mental disorders (e.g., CYCLOTHYMIC DISORDER; and BIPOLAR DISEASES).
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.