861 Clinical Trials for Various Conditions
The present study is an open trial of ketogenic diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). The investigators aim to determine whether combining standard of care pharmacological treatment for bipolar spectrum disorders with a 16-week ketogenic diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning over the study period. The experimental treatment in this study is a 16-week full ketogenic diet. Four study sites (UCLA, U Cincinnati, U Colorado and U Pittsburgh) will recruit 80 total youth (20 each) from bipolar specialty clinics. All youth eligible for the ketogenic therapy will be provided with the ketogenic diet and standard of care pharmacological treatment. During the diet therapy youth will be seen by a study child/adolescent psychiatrist at least once a month (and more frequently when needed), with the psychiatrist recommending and providing side effects monitoring and pharmacotherapy as clinically indicated. The youth and caregivers will also meet with an expert dietitian who will coach all youth on maintaining the ketogenic diet (low carbs, high fats, medium protein) and making sure the child is tolerating the diet and getting enough liquid and nutrients, following the practice guidelines of the International Ketogenic Diet Study Group for treating youth. All youth and involved caregivers will also be provided will at least one motivational enhancement session to support them in goal setting and completion of the study elements. Throughout the study the investigators will assess metabolic (e.g., blood ketones, HOMA-IR) and inflammatory indicators (e.g., C-reactive protein), both for safety reasons and to assess correlates of symptomatic change. Independent evaluators will assess youth every month regarding their symptoms (depression, mania, anxiety, psychosis), psychosocial functioning, and quality of life. The investigators anticipate that the pilot will transpire over 24 months and be an important step toward establishing feasibility and acceptability of ketogenic therapy for this population, not only in terms of diet administration and compliance but also for obtaining symptomatic, metabolic and inflammatory measurements.
Bipolar Disorder (BD), Bipolar Disorder NOS, Bipolar Disorder I or II, Bipolar Spectrum Disorder, Adolescents
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
Schizophrenia, Schizophrenia and Related Disorders, Bipolar Disorder, Bipolar and Related Disorders, Major Depressive Disorder, Major Depression Severe, Ketogenic Dieting, Ketosis, Metabolic Disease, Metabolic Syndrome
The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.
Bipolar II Disorder, Depression, Bipolar, Suicidality
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Bipolar Disorder I or II with a Major Depressive Episode
Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. Each session will be conducted on HIPAA-compliant Zoom and led by the PI (Dr. Gold).
Bipolar Disorder, Tobacco Use Disorder
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
Bipolar Disorder, Time Restricted Eating
The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of transcranial focused ultrasound (tFUS) as a treatment for bipolar disorder (BD). Specifically, the investigators will study the effects of amygdala tFUS on corticolimbic activation during an emotion regulation task in BD, the effects of amygdala tFUS on corticolimbic resting-state functional connectivity in BD, and explore the relationship between tFUS-associated changes in amygdala activity and mood symptoms. The investigators hypothesize that transcranial focused ultrasound (tFUS) of the amygdala will be associated with decreased amygdala activation and increased ventromedial prefrontal cortex activation during a modified version of the Multi-Source Interference Task (MSIT) paired with affective pictures from the International Affective Picture System (IAPS). The investigators also hypothesize that tFUS of the amygdala will be associated with increased resting-state functional connectivity between the amygdala and ventromedial prefrontal cortex. Finally, the investigators hypothesize that tFUS-associated reductions in amygdala activity could be positively correlated with reductions in depressive symptom scores and global improvement.
Bipolar
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. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.
Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anesthetics, Dissociative, Anesthetics, General, Anesthetics, Central Nervous System Depressants, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Ketamine, Depression, Unipolar, Depressive Symptoms, Treatment Resistant Depression, Major Depressive Disorder, Depression, Bipolar
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.
Bipolar Disorder, Bipolar Disorder Type 1
Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder.
Bipolar Disorder
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.
Bipolar Disorder
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.
Schizophrenia, Bipolar Disorder
The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo. The hypotheses for this study include: * Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. * Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.
Bipolar Disorder, Delayed Sleep-Wake Phase Disorder
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.
Bipolar I Disorder, Psychosis, Schizoaffective Disorder
Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning. Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims: Aim 1. To establish a machine learning algorithm using GPS/location data for predicting prospective declines in social participation in Veterans with BD. Aim 2. To establish machine learning algorithms using GPS/location data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy. Aim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.
Bipolar Disorder
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.
Time Restricted Eating, Diet, Mediterranean
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.
Bipolar Disorder
An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD).
Healthy Volunteers, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This study will investigate the safety and efficacy of bipolar disorder treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future bipolar disorder study.
Bipolar Disorder
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime and is associated with worse illness outcomes, yet few studies have been performed to clarify the causes of this comorbidity. Understanding biological risk factors that associate with and predict the development of AUDs in bipolar disorder could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in bipolar disorder aimed at capturing the mechanisms leading to the emergence of AUDs. Previous work in AUDs suggest that subjective responses to alcohol and stress-related mechanisms may contribute to the development of AUDs. In bipolar disorder, altered developmental trajectory of critical ventral prefrontal networks that modulate mood and reward processing may alter responses to alcohol and stressors; consequently, the disruption in typical neurodevelopment may be an underlying factor for the high rates of comorbidity. No longitudinal data exist investigating if this developmental hypothesis is correct. To address this gap, the investigators will use a multimodal neuroimaging approach, modeling structural and functional neural trajectories of corticolimbic networks over young adulthood, incorporating alcohol administration procedures, clinical phenotyping, and investigating effects of acute stress exposure and early life stress. Research aims are to identify biological risk factors-i.e., changes in subjective response to alcohol and associated neural trajectories-that are associated with the development of alcohol misuse and symptoms of AUDs over a two-year longitudinal period in young adults with bipolar disorder and typical developing young adults. Longitudinal data will be collected on 160 young adults (50% with bipolar disorder, 50% female; aged 21-26). This study is a natural extension of the PI's K01 award. How acute exposure to stress and childhood maltreatment affects subjective response to alcohol and risk for prospective alcohol misuse and symptoms of AUDs will be investigated. The investigators will test our hypothesis that developmental differences in bipolar disorder versus typical developing individuals disrupt corticolimbic networks during young adulthood, increase sensitivity to stress, and lead to changes in subjective response to alcohol and placebo response increasing risk for developing AUDs.
Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder
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.
Bipolar I Disorder, Depression, Anxiety, Stress
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.
Bipolar Disorder I, Bipolar II Disorder, Bipolar I Disorder, Bipolar Disorder, Bipolar Depression, Bipolar and Related Disorders, Bipolar Disorder, Type 1, Bipolar Disorder, Type 2, Bipolar Disorder, Mixed, Obesity, Metabolic Syndrome, Ketogenic Dieting, Weight Gain, Brain Metabolic Disorder, Psychotropic Agents Causing Adverse Effects in Therapeutic Use
The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder. The intervention consists of game-like exercises that involve the 'Cognitive Control of Emotion (CCE) - i.e. the ability to control the influence of emotional information on behavior. Deficits in the cognitive control of emotion are a central feature of Bipolar Disorder that contributes to emotion dysregulation, maladaptive mood episodes, and, ultimately, the overall chronicity and severity of illness. Neuroimaging studies of bipolar patients demonstrate neural abnormalities in brain systems involved in cognitive control and emotion processing. Furthermore, these abnormalities predict mood and behavior problems associated with cognitive control of emotion, such as emotion lability, disinhibited behavior, and extreme mood states. The aim of this study is to determine feasibility and examine whether a computer-based program of progressively difficult cognitive control emotion exercises will improve cognitive control of emotion skills and, thereby, result in better emotion regulation and daily functioning in young adults with bipolar disorder. To test the intervention, a single group of young adults (18-30 years old) with Bipolar I Disorder will complete behavioral assessments before and after 20 hours (4 weeks) of CCE training. In order to identify baseline deficits associated with bipolar disorder, a comparison group of healthy young adults will complete behavioral assessments at a single time-point (without CCE training).
Bipolar Disorder, Bipolar I Disorder, Bipolar Affective Disorder, Bipolar Disorder I, Bipolar Depression
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. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders. Objective: To better understand relationships among physical activity, sleep, and mental health. Eligibility: People aged 12 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed. Design: Participants will be in the study up to 2 years. For up to 20 days in a row, at 4 times during the study, participants will: Complete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities. Wear an activity monitor, like a wristwatch, that records how much they move. Wear a light sensor, as a necklace, to record the amount of light in their environment. Some participants will do additional tests. Twice during the study, for 3 days in a row, they will: Wear monitors to record their temperature, heart rate, and sleep. Provide saliva samples. Complete cognitive tasks on their smartphone. Participants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan. Some participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.
Bipolar Disorder, Major Depression, Migraine
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.
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.
Bipolar Disorder
Transcranial light therapy, or transcranial photobiomodulation (tPBM), is a treatment that stimulates the brain by applying near-infrared light to the forehead. Transcranial light therapy has been found to promote brain metabolism, which may help improve executive function in people with bipolar disorder. The research team proposes a novel approach to treating bipolar disorder by using transcranial light therapy.
Bipolar Disorder