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Bipolar I Disorder clinical trials

View clinical trials related to Bipolar I Disorder.

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NCT ID: NCT04771299 Recruiting - Clinical trials for Cognitive Impairment

Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients

CARPZ-01
Start date: July 7, 2021
Phase: Phase 3
Study type: Interventional

Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR®) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.

NCT ID: NCT04578756 Recruiting - Schizophrenia Clinical Trials

Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.

NCT ID: NCT04561622 Active, not recruiting - Bipolar Disorder Clinical Trials

Emotional Proactive Processing in Bipolar Disorder

PROEMO_BP
Start date: October 1, 2020
Phase:
Study type: Observational

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

NCT ID: NCT04315792 Recruiting - Bipolar I Disorder Clinical Trials

Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Start date: March 23, 2020
Phase: Phase 3
Study type: Interventional

The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.

NCT ID: NCT04211428 Recruiting - Bipolar Disorder Clinical Trials

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder

Start date: March 2, 2020
Phase:
Study type: Observational

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

NCT ID: NCT04209140 Active, not recruiting - Bipolar I Disorder Clinical Trials

Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative

R-LiNK
Start date: January 10, 2020
Phase:
Study type: Observational

Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response. The objectives of this project are to: - improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches - optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers) - develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and - implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders. This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.

NCT ID: NCT04127058 Completed - Schizophrenia Clinical Trials

Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

Start date: October 7, 2019
Phase: Phase 1
Study type: Interventional

This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.

NCT ID: NCT04030143 Completed - Schizophrenia Clinical Trials

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Start date: August 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

NCT ID: NCT03943537 Recruiting - Schizophrenia Clinical Trials

Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders

Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.

NCT ID: NCT03919760 Recruiting - Schizophrenia Clinical Trials

Early Psychosis Intervention - Spreading Evidence-based Treatment

EPI-SET
Start date: January 3, 2020
Phase:
Study type: Observational

Implementation of 'NAVIGATE' in Ontario aims to help youth and emerging adults suffering from a first episode of psychosis. Although Ontario already has early psychosis intervention programs, the team's recent work has identified major challenges of delivering coordinated care, particularly those elements of care that enhance recovery. These challenges also exist nationally and internationally. By building on the already existing early psychosis intervention community of practice through the Early Psychosis Intervention Ontario Network, the investigators will implement NAVIGATE with the help of CAMH's Provincial System Support Program facilitators. The use of tele-videoconferencing through ECHO Mental Health Ontario and ECHO processes and protocols provide us with an opportunity to ensure sustainability. Using health administrative data held at the Institute for Clinical Evaluative Sciences (ICES), the investigators can examine system-level outcomes, including hospitalizations, emergency department visits, and outpatient physician visits of youth and emerging adults suffering from a first episode psychosis who are treated with NAVIGATE compared with those treated in early psychosis intervention programs without NAVIGATE and those who are not treated in early psychosis intervention programs. In addition, the investigators can also evaluate health care costs. Prior to initiating this project, the investigators obtained the input of youth and emerging adults with a first episode psychosis and family members. The investigators will also continue to measure engagement across the study. Hypotheses: 1. Following the implementation of NAVIGATE, program fidelity (i.e. adaptability) to the Ontario early psychosis intervention standard will improve. 2. Compared to patients not receiving NAVIGATE, those who receive NAVIGATE through this implementation study will have fewer days in hospital, fewer emergency department visits, fewer suicide attempts, lower mortality, and lower healthcare costs. 3. Improvements in functioning and symptoms will be comparable to the RAISE study (an earlier study assessing NAVIGATE); improvement may be influenced by demographic, socio-economic, geographic, and clinical factors. 4. The project's engagement approach will demonstrate that the investigators used the full range of patient engagement based on objectively assessed engagement metrics.