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Showing 1-20 of 40 trials
NCT07540338
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: * How safe is AL001 when compared to lithium carbonate? * How is AL001 broken down in the brain and body compared to lithium carbonate? Participants will be asked to: * Take both the study drug (AL001) and lithium carbonate each for a period of 14 days. * Stay overnight at MGH's research unit for two separate 2-week periods. * Participate in two separate 24 hour periods of multiple MRIs and blood draws.
NCT07494305
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.
NCT07172516
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 depressive episode (bipolar depression).
NCT07288320
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.
NCT07213466
The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: * Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.
NCT06804525
The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use disorders over varying time frames (30 days, 12 months, and lifetime) based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) and International Classification of Diseases 10th edition (ICD-10). However, retrospective measurements like the CIDI-5 are susceptible to recall bias, especially for the lifetime experience, which can hinder the reporting accuracy with mental disorders. To mitigate this issue, the life history calendar (LHC) was introduced as an aid to assist respondents in recalling the timing of life events, enhancing the ability of the CIDI-5 to measure the lifetime prevalence of mental disorders. The LHC is a grid structure with columns representing time units and rows representing life domains under study. In a study conducted in Nepal, combining the CIDI-5 with the LHC resulted in a significant increase in the detection of mental disorders compared to using the CIDI-5 alone. This approach did not lead to an increase in false positives after clinical validation. This experiment aims to adapt a Hong Kong version of the LHC based on the Nepalese model and evaluate the effectiveness of the LHC-assisted CIDI-5 (LHC-CIDI-5) compared to the CIDI-5 alone in assessing mental disorders.
NCT04987229
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
NCT05303064
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
NCT05837104
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.
NCT06433635
This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 and type 2 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).
NCT05658510
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
NCT03788811
This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I. They involve the processing and analysis of specific retinal biosignatures (RSPA) with the support of statistical and mathematical modelling processes e.g. machine learning and statistical learning.
NCT06273774
The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
NCT04771299
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.
NCT04315792
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.
NCT05965232
Background: Severe psychiatric diseases (schizophrenia, bipolarity, depression, anxious syndrome) are often associated with a metabolic syndrome, including Non-Alcoholic Steato Hepatitis, probably misdiagnosed in patients with psychiatric illness. Furthermore, long-term exposition to substances like alcohol or to one or more psychotropic treatments may involve liver detoxification role. Thanks to liver stiffness, based on FibroScan®, and CAP (controlled attenuation parameter), we wanted to study prevalence of severe fibrosis and steatosis in this population. Material \& Methods: Prospective study of 385 subjects hospitalised in a psychiatric hospital for schizophrenia, bipolar disorder, depression or anxiety-depression disorder and receiving psychotropic treatment for at least 2 years, for whom a FibroScan®, a blood test and a record of clinical data were carried out, after information and informed consent. Benefits expected : This study should show an expected excess risk of fibrosis. FibroScan® in this population and determine the risk factors more associated risk factors. Generalized or targeted screening for identified risk factors in this population could help optimize in this population could help optimize the choice and dosage of psychotropic of psychotropic drugs, and above all, help to guide the strategy of hepatic and prevention strategy.
NCT05705063
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.
NCT03187769
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
NCT04907279
To characterize the real-life clinical use of AOM in a hospitalized patient population with schizophrenia, schizoaffective disorder or BP1 requiring LAI therapy and evaluate its short-term effectiveness associated with its clinical use in the proposed patient population, including time to discharge, efficacy, safety, tolerability, and patients' satisfaction.
NCT01059539
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.