Clinical trials: Bipolar Disorder I
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 1 Disorder
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania…
- Trial name
- NCT07046494
- Testing
- RAP-219
- Where
- 20 sites in United States
- Volunteers
- 253 people
- Sponsor
- Rapport Therapeutics 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
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
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, Bipolar II Disorder
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity 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 in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II…
- Trial name
- CANTO (NCT06605599)
- Testing
- ABBV-932
- Where
- 40 sites in United States, Japan and 1 more
- Volunteers
- 161 people
- Sponsor
- AbbVie
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
Bipolar Disorder, Bipolar Depression
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a…
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- X-CEED (NCT07172516)
- Testing
- Azetukalner
- Where
- 44 sites in United States, Bulgaria and 2 more
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar Depression, Bipolar I Disorder
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar…
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder
- Trial name
- NCT07217860
- Testing
- Azetukalner
- Where
- 20 sites in United States
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar Disorder
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.
- Trial name
- NCT07286175
- Testing
- Brenipatide
- Where
- 87 sites in United States, Argentina and 6 more
- Volunteers
- 400 people
- Sponsor
- Eli Lilly and Company
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics 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
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 Disorder
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
- Conditions
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
- Trial name
- NCT06229210
- Testing
- Lumateperone
- Where
- 65 sites in United States, Colombia and 1 more
- Volunteers
- 300 people
- Sponsor
- Intra-Cellular Therapies, Inc.
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.
Bi-Polar Disorder, Autism Spectrum Disorder (ASD)
An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
- Conditions
- Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders, Separation Anxiety Disorder
- Trial name
- NCT07329673
- Testing
- Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Qbtech AB
Bipolar I or II Disorder
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with…
- Trial name
- NCT07220460
- Testing
- ABBV-932
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 84 people
- Sponsor
- AbbVie
Schizophrenia, Schizoaffective Disorder
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder
- Trial name
- NCT07105111
- Testing
- Valbenazine
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Neurocrine Biosciences
Bipolar Disorder
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder
This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.
- Trial name
- NCT07071532
- Testing
- ABBV-932, Itraconazole
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- AbbVie
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.