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Disease

Mania

Late-stage therapeutic developmentEmerging research
MeSHMania
1
Publications
24
Clinical trials
2024
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

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.
  • 3 industry developments reported.
Upcoming Milestones
Clinical Milestones7View
Results expected 5
Recently completed 1
Other updates 1
Industry & Market3View
Activity timeline10

Clinical trials

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

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 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

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

Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study

Phase 3 · Recruiting · Douglas Mental Health University Institute

Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial

Phase 3 · Recruiting · University of British Columbia

A 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

Phase 3 · Recruiting · Bristol-Myers Squibb

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Phase 4 · Recruiting · Mayo Clinic
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 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

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

Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study

Phase 3 · Recruiting · Douglas Mental Health University Institute

Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial

Phase 3 · Recruiting · University of British Columbia

A 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

Phase 3 · Recruiting · Bristol-Myers Squibb

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Phase 4 · Recruiting · Mayo Clinic
Recently completed

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

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

A 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 Disorder

Phase 3 · Completed · AbbVie

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

A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

Phase 2/3 · Completed · Biohaven Therapeutics Ltd.

A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)

Phase 3 · Completed · Lakshmi N Yatham

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Phase 3 · Completed · Alkermes, Inc.

Research activity

1 paper

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Most influential

Adolescent Psychedelic Use and Psychotic or Manic Symptoms.

JAMA psychiatry · 2024 · 17 cites
Recent publications

Adolescent Psychedelic Use and Psychotic or Manic Symptoms.

JAMA psychiatry · 2024 · 17 cites
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
MeSHMania
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.