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Bipolar Disorder clinical trials

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NCT ID: NCT06431386 Recruiting - Bipolar Disorder Clinical Trials

Behavioural Activation Therapy and Esketamine for Resistant Depression

Start date: June 2024
Phase: N/A
Study type: Interventional

This is a randomized clinical trial to test the effectiveness of combining a proven psychological intervention called behavioural activation therapy alongside esketamine treatment for treatment resistant major depressive episodes in individuals with major depressive disorder or bipolar disorder. Encouraging participants to practice new behaviours while their mood is improved through esketamine treatment may lead to more lasting recovery from depression.

NCT ID: NCT06424613 Recruiting - Bipolar Disorder Clinical Trials

Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China

Start date: April 18, 2024
Phase:
Study type: Observational

This study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in China.The primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in China. Secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.

NCT ID: NCT06419582 Recruiting - Bipolar Disorder Clinical Trials

BHV-7000 Acute Treatment of Bipolar Mania

Start date: May 28, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.

NCT ID: NCT06417437 Recruiting - Depression Clinical Trials

Non-invasive BCI and Application Verification for Depressed People

Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people. At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms. In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies. This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments. This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect.

NCT ID: NCT06399523 Recruiting - Bipolar Disorder Clinical Trials

A Study to Evaluate the Efficacy of VR for Bipolar Disorder

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Bipolar disorder is characterized by high morbidity, recurrence, disability, suicide and comorbidity rate which need novel, efficient, and safe treatment methods, and VR has demonstrate its efficacy in mental disease but not few focus on bipolar disorder. A prospective single center randomize clinical study therefore would be carried on to evaluate the efficacy of VR for Bipolar Disorder in China.

NCT ID: NCT06384755 Recruiting - Bipolar Disorder Clinical Trials

Honest Open Proud for Psychotic and Bipolar Disorder in Norway

HOP-NOR
Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting.

NCT ID: NCT06373016 Recruiting - Bipolar Disorder Clinical Trials

Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior.

NCT ID: NCT06372964 Recruiting - Bipolar Depression Clinical Trials

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Start date: April 2024
Phase: Phase 3
Study type: Interventional

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 confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

NCT ID: NCT06369792 Recruiting - Bipolar Disorder Clinical Trials

PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION

Start date: October 20, 2020
Phase:
Study type: Observational

This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.

NCT ID: NCT06365021 Recruiting - Bipolar Disorder Clinical Trials

ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated: - The efficacy of ACT in reducing depressive symptoms in patients with BD. - The efficacy of ACT in improving the quality of life in patients with BD. - The efficacy of ACT in improving functionality in patients with BD. - The efficacy of ACT in improving sleep quality in patients with BD. - The efficacy of ACT in improving psychological flexibility in patients with BD Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment. Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment. Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment. Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder.