Bipolar disorder clinical trials, in English

This study wants 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 comorbidity.

NCT03829787 · Official ClinicalTrials.gov record · University Hospitals Cleveland Medical Center

Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk.

NCT04877977 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

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.

NCT05669703 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

NCT06229210 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation.

NCT06370988 · Official ClinicalTrials.gov record · Centre for Addiction and Mental Health

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments.

NCT06462196 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)

Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior.

NCT06507787 · Official ClinicalTrials.gov record · Alcediag

This study wants to assess antidepressant how well it works differences between ALTO-100 and dummy treatment (placebo) during the neither you nor the study doctors know who gets the real treatment period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and how well it works will be assessed in a subsequent open label treatment period.

NCT06656416 · Official ClinicalTrials.gov record · Alto Neuroscience

Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6).

NCT06872398 · Official ClinicalTrials.gov record · Fondation FondaMental

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 measure the long-term whether it is safe and how hard side effects are to live with of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

NCT06929273 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active dummy treatment (placebo) (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e.

NCT06943573 · Official ClinicalTrials.gov record · Lakshmi N Yatham

This is a Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to measure the how well it works of KarXT compared to dummy treatment (placebo) in treating symptoms of mania during a 3-week inpatient period.

NCT06951711 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

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) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism.

NCT07101107 · Official ClinicalTrials.gov record · Medical University Innsbruck

This study wants to measure the how well it works and safety of added on top of your current treatment KarXT for the treatment of mania in participants with Bipolar-I Disorder.

NCT07140913 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This is a randomly assigned 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 least mildly depressed. Following a 1-week baseline assessment, you would be randomly assigned to either a TRE or the wait list (1-to-1 ratio) for 8 weeks.

NCT07211217 · Official ClinicalTrials.gov record · Massachusetts General Hospital

People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations.

NCT07213492 · Official ClinicalTrials.gov record · McMaster University

This randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled clinical trial aims to measure the how well it works and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. you would be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care.

NCT07246044 · Official ClinicalTrials.gov record · Jiangsu Province Nanjing Brain Hospital

This study wants to assess the how well it works and safety of brenipatide when administered with standard of care (SoC), compared with dummy treatment (placebo) plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months.

NCT07286175 · Official ClinicalTrials.gov record · Eli Lilly and Company

The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders. The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs.

NCT07404085 · Official ClinicalTrials.gov record · Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include: * Aerobic exercise * Controlled breathing (cyclic sighing) * Aromatherapy with lavender essential oil * Listening to specific music (Solfeggio 528 Hz) * Virtual reality relaxation with forest imagery * Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.

NCT07437833 · Official ClinicalTrials.gov record · Poznan University of Physical Education

The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is: Does IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?

NCT07569198 · Official ClinicalTrials.gov record · Joshua Rosenblat

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 suicide.

NCT07664852 · Official ClinicalTrials.gov record · Daniel Lindqvist

This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation.

NCT07745374 · Official ClinicalTrials.gov record · Icahn School of Medicine at Mount Sinai

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 anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60.

NCT07881016 · Official ClinicalTrials.gov record · Fondation FondaMental

This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms. The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China.

NCT07903246 · Official ClinicalTrials.gov record · Second Affiliated Hospital, Zhejiang University, School of Medicine

The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives. The investigators hypothesize that targeted affective cognitive training, compared with treatment as usual, will improve affective cognition (primary outcome), assessed using a composite measure of emotion regulation and facial emotion recognition.

NCT07920302 · Official ClinicalTrials.gov record · Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital