Clinical trials: Bipolar I Disorder, active
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-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
Schizophrenia Disorder, Schizoaffective Disorder
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
This study is a randomized controlled trial evaluating the impact of financial incentives on medication adherence among individuals with schizophrenia, schizoaffective disorder, or bipolar disorder and/or co-occurring substance…
- Conditions
- Schizophrenia Disorder, Schizoaffective Disorder, Bipolar Disorder (BD), Substance Use Disorder (SUD)
- Trial name
- NCT07130500
- Testing
- Financial incentives for adherence to long-acting injectable medication, Standard of care with monthly surveys
- Where
- 6 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Stanford University
Bipolar Disorder (BD)
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of…
- Trial name
- B-HAPPI (NCT07664852)
- Testing
- Pramipexole
- Where
- Sweden
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Daniel Lindqvist
Bipolar Disorder (BD), Quality of Life (QOL)
Evaluating the PolarUs App in People With Bipolar Disorder
Our team recently pilot tested a new mobile app, PolarUs, co-designed with people who live with bipolar disorder (BD), to support BD self-management and quality of life (QoL) measurement.
- Trial name
- NCT07890805
- Testing
- PolarUs Mobile App
- Where
- Canada
- Volunteers
- 504 people
- Sponsor
- University of British Columbia
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
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
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and…
- Conditions
- Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP), Bipolar Disorder (BD), Major Depressive Disorder (MDD
- Trial name
- FRENCH-MINDS (NCT07881016)
- Testing
- 3T Brain MRI, Biological Sampling, Clinical, Cognitive and Digital Assessments
- Where
- 17 sites in France
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Fondation FondaMental
Schizophenia Disorder, Severe Mental Illness
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with significant impairments in psychosocial functioning, daily life participation, self-efficacy, and social…
- Conditions
- Schizophenia Disorder, Severe Mental Illness, Bipolar Disorder, Nonorganic Psychosis
- Trial name
- OT-SMI (NCT07879118)
- Testing
- Occupational Therapy Group Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Biruni University
Severe Mental Illness, Bipolar Disorder
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
The goal of this clinical trial is to learn whether MoodSync, a mobile application for patients and their family caregivers, improves mood stability, medication adherence, daily functioning and early detection of relapse warning…
- Conditions
- Severe Mental Illness, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- MoodSync (NCT07879131)
- Testing
- MoodSync, Standard care
- Where
- Bahrain
- Volunteers
- 60 people
- Sponsor
- Alexandria University
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 Disorder (BD)
BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder
Bipolar disorder (BD) is often diagnosed 5 to 10 years after first symptoms, worsening prognosis. "Bipolar At-Risk" (BAR) criteria have been developed to identify people who may be in an early, prodromal stage of BD, but their…
- Trial name
- BAROMETRE (NCT07872878)
- Testing
- Structured clinical follow-up and psychometric assessment
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Angers
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
Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder
The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder…
- Trial name
- NCT03829787
- Testing
- Eye tracking
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Bipolar Disorder, Major Depression
NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
Background: Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances.
- Conditions
- Bipolar Disorder, Major Depression, Migraine
- Trial name
- NCT05669703
- Where
- United States
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- National Institute of Mental Health (NIMH)
Bipolar 1 Disorder, Control Subjects
Socio-cognitive and Biological Responses to Maltreatment
The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation)…
- Trial name
- NCT07101107
- Where
- Austria
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Bipolar Disorder (BD), Bipolar Disorder Depression
Time Restricted Eating (TRE) in Bipolar Disorder
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at…
- Conditions
- Bipolar Disorder (BD), Bipolar Disorder Depression, Overweight (BMI > 30)
- Trial name
- TREBD (NCT07211217)
- Testing
- Time Restricted Eating
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
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