Clinical trials: Bipolar 1 Disorder, active
Depression - Major Depressive Disorder, Depression Bipolar
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.
- Trial name
- NCT07026461
- Testing
- repetitive transcranial magnetic stimulation, intermittent theta burst stimulation
- Where
- 2 sites in Sweden
- Volunteers
- 350 people
- Sponsor
- Region Örebro County
Bipolar I Disorder, Bipolar II Disorder
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity
- Trial name
- OBOE-Mayo (NCT07213466)
- Testing
- Group Therapy Program, semaglutide, Phentermine-Topiramate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
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 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, Depression, Anxiety
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress…
- Conditions
- Bipolar I Disorder, Depression, Anxiety, Stress
- Trial name
- NCT05837104
- Testing
- Magnesium vitamin B6
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Mclean Hospital
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 Disorder, Bipolar Disorder Type 1
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar.
- Trial name
- NCT06373016
- Testing
- Glucose, Ketones
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
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.
Major Depressive Disorder, Bipolar I Disorder
Digital Phenotypes for Predicting Depression_Validation
This 12-month, single-site prospective observational study will prospectively monitor the recurrence of mood episodes while continuously collecting passive digital phenotypes in individuals with and without mood disorders.
- Conditions
- Major Depressive Disorder, Bipolar I Disorder, Bipolar II Disorder, Mood Disorders
- Trial name
- NCT07880015
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Korea University Anam Hospital
Bipolar Disorder, Alcohol Use Disorder
N-Acetylcysteine for Bipolar and Alcohol Use Disorders
This study will evaluate N-acetylcysteine (NAC) in adults with bipolar disorder and alcohol use disorder. Participants will be randomly assigned to receive NAC or matched placebo for 28 days.
- Trial name
- NCT07913542
- Testing
- N-acetyl cysteine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Medical University of South Carolina
Bipolar I Disorder
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived…
- Trial name
- NCT05977023
- Testing
- NMDAE
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- China Medical University Hospital
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
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.
Alzheimer Disease, Dementia With Lewy Bodies (DLB)
Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies (DLB), Frontotemporal Dementia (FTD), Major Depressive Disorder (MDD)
- Trial name
- Synapsing-BK (NCT07314190)
- Where
- Spain
- Volunteers
- 1,799 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Bipolar Depression, Bipolar I Disorder
SYNCED - SYNChronized Eating in Bipolar Depression Study
Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment.
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT06560957
- Testing
- Time restricted eating, Eating ad libitum with nutritional counselling
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Ottawa
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
Major Depressive Disorder (MDD), Schizophenia Disorder
Prospective Observational Study of the Relationship Between Sociodemographic Factors, Blood-based Biomarkers and Psychiatric Symptoms in Neurodegenerative Diseases and Mental Disorders
This is a prospective observational study to identify sociodemographic factors that predict mental health outcomes in the European population and provide evidence linking common, modifiable sociodemographic risk factors for…
- Conditions
- Major Depressive Disorder (MDD), Schizophenia Disorder, Bipolar 1 Disorder, Alzheimer Disease
- Trial name
- Synapsing-SD (NCT07239843)
- Where
- Spain
- Volunteers
- 1,310 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Bipolar I Disorder, Psychosis
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar…
- Conditions
- Bipolar I Disorder, Psychosis, Schizoaffective Disorder
- Trial name
- NCT06221852
- Testing
- Ketogenic diet, Dietary Guidelines for Americans
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mclean Hospital
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.