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Bipolar I Disorder clinical trials

View clinical trials related to Bipolar I Disorder.

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NCT ID: NCT06273774 Not yet recruiting - Bipolar I Disorder Clinical Trials

A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.

NCT ID: NCT06256367 Not yet recruiting - Bipolar I Disorder Clinical Trials

Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

CReW BP-I
Start date: February 7, 2024
Phase:
Study type: Observational

Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices. Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study. Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.

NCT ID: NCT06221852 Recruiting - Clinical trials for Schizoaffective Disorder

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

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 disorder and schizoaffective disorder.

NCT ID: NCT06129500 Recruiting - Bipolar Disorder Clinical Trials

CBT for Problematic Impulsive Behaviours in Bipolar Disorder: A Case Series / CBT-PIB

Start date: August 17, 2023
Phase: N/A
Study type: Interventional

The goal of this case series is to explore whether a talking therapy, specifically Cognitive Behavioural Therapy (CBT) is acceptable and feasible in the management of mood-driven impulsive behaviours in people with bipolar disorder (BD). The main questions it aims to answer are: - Whether CBT Is a feasible intervention for participants with BD who report mood-driven, problematic impulsive behaviours. - Whether CBT for mood-driven, problematic impulsive behaviours (CBT-PIB) is acceptable to service users with BD and therapists. - Whether clinical outcomes are consistent with the potential for this novel intervention to offer clinical benefit to participants with BD. The study also hopes to: - conduct a preliminary examination of the safety of CBT-PIB and the research procedures. - gather information on the potential mechanisms of action of CBT-PIB and, - gather information on the types of mood-driven impulsive behaviours individuals with BD may seek support for. Participants will: - be offered up to 12 individual sessions of CBT focusing on mood-driven impulsive behaviours. - be asked to complete a battery of self-report measures (5) when they enter the study and at the start and end of treatment. - be asked to track mood and impulsive behaviours by completing a brief set of measures (3) weekly during the two-week baseline phase, the intervention phase and the 2-week post-intervention phase. - be asked to complete a survey on the acceptability of the intervention and - be invited to an optional semi-structured interview on their research experience.

NCT ID: NCT05977023 Recruiting - Bipolar I Disorder Clinical Trials

NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

Start date: October 4, 2023
Phase: Phase 2
Study type: Interventional

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 stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.

NCT ID: NCT05956483 Not yet recruiting - Bipolar I Disorder Clinical Trials

Study to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World Setting

Start date: July 15, 2023
Phase:
Study type: Observational

Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1. Rapid Mood Screener (RMS) is a brief 6-item clinician-administered checklist, in which a participant's endorsement of four or more questions should trigger further clinical evaluation for BP1. Approximately 404 participants (303 with confirmed unipolar MDD and 101 with confirmed BP1) will be enrolled in the United States. Participants will be answering RMS questionnaire and accuracy will be measured against Mini-International Neuropsychiatric Interview (MINI) interview.

NCT ID: NCT05956340 Recruiting - Bipolar I Disorder Clinical Trials

A Study of Spoken Language in Mania

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This research is being done to find if there are changes with voice and speech during episodes of mania.

NCT ID: NCT05878808 Completed - Clinical trials for Obsessive-Compulsive Disorder

Obsessions and Suicidality in Youth With Bipolar 1 Disorder

Start date: February 1, 2022
Phase:
Study type: Observational

Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a comorbidity that is known to increase suicide risk. This study aimed to assess the presence of OCD in youth diagnosed with bipolar I disorder & to evaluate the association between OCD and suicide in the same cohort. Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS). The results revealed that DYBOCS score of group A was 30.23±0.43, & of group B was 18.50±1.88 with a significant difference (p<0.01). There was a significantpositive correlation between BSSI and age, age of onset and YMRS in Group A (p<0.01). The study demonstrated that OCD is a common comorbidity in youth with bipolar I disorder and may be associated with a greater risk of suicide than in youth with bipolar I disorder without co-morbid OCD. Furthermore, co-morbidity of OCD with bipolar I disorder in youth may be associated with younger age of onset and more severe symptoms profile.

NCT ID: NCT05837104 Recruiting - Stress Clinical Trials

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Start date: December 13, 2023
Phase: Phase 2
Study type: Interventional

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, and anxiety in patients with first episode bipolar I disorder.

NCT ID: NCT05705063 Not yet recruiting - Obesity Clinical Trials

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.