bipolar I disorder

Summary

bipolar I disorder (MONDO:0001866) is a disease and 145 clinical trials. Top therapeutic interventions include cariprazine, quetiapine, and valproic acid. A subtype of bipolar disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 145

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	bipolar I disorder
Mondo ID	MONDO:0001866
DOID	DOID:14042
SNOMED CT	371596008
UMLS	C0853193
MedGen	678499
Is cancer (heuristic)	no

Also known as: bipolar 1 disorder

Disease family

This is a subtype of bipolar disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by developmental or physiological process › psychiatric disorder › mental disorder › mood disorder › bipolar disorder › bipolar I disorder

Related subtypes (11): bipolar II disorder, major affective disorder 1, major affective disorder 3, major affective disorder 4, major affective disorder 5, major affective disorder 6, major affective disorder 8, major affective disorder 7, major affective disorder 9, manic bipolar affective disorder, bipolar depression

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

No druggable-target or therapeutic data for this disease’s cohort.

Clinical trials & evidence

Clinical trials

Clinical trials: 145.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	49
PHASE3	47
PHASE2	23
PHASE4	15
PHASE1	7
PHASE1/PHASE2	3
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04580134	PHASE4	RECRUITING	CLOZAPINE Response in Biotype-1
NCT05648591	PHASE4	RECRUITING	Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
NCT06433635	PHASE4	ACTIVE_NOT_RECRUITING	Sequential Multiple Assignment Randomized Trial for Bipolar Depression
NCT07213466	PHASE4	RECRUITING	Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
NCT00178061	PHASE4	COMPLETED	Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder
NCT00350857	PHASE4	COMPLETED	The Young Adult and Pediatric Bipolar Study
NCT00402324	PHASE4	COMPLETED	A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
NCT00608075	PHASE4	UNKNOWN	Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
NCT00976794	PHASE4	COMPLETED	Efficacy of Combined Treatment for Young Bipolar I Disorder
NCT00982020	PHASE4	COMPLETED	Study in Adolescents With Schizophrenia or Bipolar Disorder
NCT01495156	PHASE4	WITHDRAWN	Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
NCT01588457	PHASE4	COMPLETED	Sequential Multiple Assignment Treatment for Bipolar Disorder
NCT01710163	PHASE4	UNKNOWN	Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
NCT03156504	PHASE4	COMPLETED	The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
NCT03643159	PHASE4	TERMINATED	A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
NCT04777357	PHASE3	RECRUITING	A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
NCT04987229	PHASE3	ENROLLING_BY_INVITATION	Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
NCT05303064	PHASE3	RECRUITING	Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
NCT06608641	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
NCT07172516	PHASE3	RECRUITING	A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
NCT07217860	PHASE3	ENROLLING_BY_INVITATION	An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
NCT00046384	PHASE3	COMPLETED	Study of Aripiprazole in the Treatment of Patients With Acute Symptoms of Bipolar Disorder
NCT00094432	PHASE3	COMPLETED	A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
NCT00107731	PHASE3	COMPLETED	Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
NCT00114686	PHASE3	COMPLETED	Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
NCT00177164	PHASE3	COMPLETED	Risperdal Consta for Bipolar Disorder
NCT00195780	PHASE3	COMPLETED	A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
NCT00227305	PHASE3	COMPLETED	Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
NCT00228059	PHASE3	COMPLETED	An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
NCT00232414	PHASE3	COMPLETED	A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
NCT00238485	PHASE3	COMPLETED	An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder
NCT00606177	PHASE3	COMPLETED	A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
NCT00606229	PHASE3	COMPLETED	A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
NCT00606281	PHASE3	COMPLETED	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
NCT00606320	PHASE3	COMPLETED	A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
NCT00618748	PHASE3	COMPLETED	Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
NCT00721955	PHASE3	COMPLETED	Staccato Loxapine in Agitated Patients With Bipolar Disorder
NCT00761761	PHASE3	COMPLETED	Sensoril(Ashwaganhda)for Bipolar Disorder
NCT00764478	PHASE3	COMPLETED	Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
NCT00857818	PHASE3	TERMINATED	Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
CARIPRAZINE	4	21
QUETIAPINE	4	12
VALPROIC ACID	4	10
LURASIDONE	4	5
ASENAPINE	4	4
BREXPIPRAZOLE	4	4
ILOPERIDONE	4	4
KETAMINE	4	3
MIDAZOLAM	4	3
NALTREXONE	4	3
LAMOTRIGINE	4	2
OLANZAPINE	4	2
ARIPIPRAZOLE	4	1
BETAHISTINE	4	1
CARBAMAZEPINE	4	1
CLOZAPINE	4	1
ESLICARBAZEPINE	4	1
ESLICARBAZEPINE ACETATE	4	1
FLUPHENAZINE DECANOATE	4	1
LITHIUM CARBONATE	4	1
SEMAGLUTIDE	4	1
LITHIUM	3	6
AZETUKALNER	3	2
LICARBAZEPINE	3	2
AFIMOXIFENE	3	1
BIFEPRUNOX	3	1
CARNOSINE	3	1
ENDOXIFEN	3	1
LATOZINEMAB	3	1
ICALCAPRANT	2	1