Clinical trials: Bipolar I Disorder, open to volunteers
- Condition Bipolar I Disorder
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
- Trial name
- NCT06951711
- Testing
- KarXT
- Where
- 85 sites in United States, China and 9 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Bipolar I Disorder, Bipolar II Disorder
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- NCT06696755
- Testing
- Icalcaprant
- Where
- 33 sites in United States
- Volunteers
- 195 people
- Sponsor
- AbbVie
Mania, Bipolar Disorder
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
- Trial name
- NCT07140913
- Testing
- Xanomeline/Trospium Chloride
- Where
- 109 sites in United States, Argentina and 11 more
- Volunteers
- 424 people
- Sponsor
- Bristol-Myers Squibb
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar I Disorder
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo).
- Trial name
- Illuminate1 (NCT07494305)
- Testing
- LB-102
- Where
- 26 sites in United States
- Volunteers
- 320 people
- Sponsor
- LB Pharmaceuticals Inc.
Bipolar Disorder I or II With a Major Depressive Episode
ALTO-100 in Bipolar Disorder With Depression (BD-D)
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used…
- Trial name
- NCT06656416
- Testing
- ALTO-100
- Where
- 68 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Alto Neuroscience
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Bipolar I Disorder, Schizophrenia
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
- Trial name
- NCT04987229
- Testing
- OLZ/SAM
- Where
- 35 sites in United States, Argentina and 3 more
- Volunteers
- 236 people
- Sponsor
- Alkermes, Inc.
Schizophrenia, Bipolar I Disorder
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
- Trial name
- NCT05648591
- Testing
- Iloperidone
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Schizophrenia, Bipolar I Disorder
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral…
- Conditions
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Trial name
- NCT07185815
- Testing
- Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day
- Where
- 6 sites in India, Israel
- Volunteers
- 24 people
- Sponsor
- Mapi Pharma Ltd.
Depression, Bipolar I Disorder
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.
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- 3112 Ped BPD (NCT04777357)
- Testing
- Cariprazine
- Where
- 81 sites in United States, Puerto Rico and 1 more
- Volunteers
- 380 people
- Sponsor
- AbbVie
Schizophrenia, Bipolar Affective Disorder
Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder
The goal of this observational study is to evaluate the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine monotherapy or in…
- Trial name
- NCT07858565
- Testing
- Quetiapine (drug), quetiapine + aripiprazole, quetiapine + haloperidol
- Where
- Bosnia and Herzegovina
- Volunteers
- 500 people
- Sponsor
- Bosnalijek D.D
Bipolar I Disorder
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder.
- Trial name
- NCT07540338
- Testing
- AL001, Lithium carbonate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alzamend Neuro, Inc.
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Schizophrenia, Bipolar I Disorder
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
- Trial name
- NCT05303064
- Testing
- OLZ/SAM, Olanzapine
- Where
- 47 sites in United States, Argentina and 3 more
- Volunteers
- 220 people
- Sponsor
- Alkermes, Inc.
Bipolar-I Disorder With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
- Trial name
- BALSAM-1 (NCT06951698)
- Testing
- KarXT
- Where
- 74 sites in United States, Argentina and 7 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Healthy Adult Participants
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
This is a Phase 1, open-label, 5-period, 2-sequence, single ascending dose study designed to assess the pharmacokinetics, dose proportionality, safety, and tolerability of NRL-1004 (olanzapine nasal spray), and to assess the…
- Trial name
- NCT07921966
- Testing
- NRL-1004 2.5 mg, ZYPREXA IM 10mg, NRL-1004 5.0 mg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurelis, Inc.