Bipolar Disorder Clinical Trials

This research study is designed to look at the involvement of the glutamate system in depression. Each subject will undergo a screening appointment to determine study eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule availability and will consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing. Depending on camera time, staff availability and subject schedule, total study participation may last 1-2 months. Read Less

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions. Read Less

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. Read Less

Suicide rates among Veterans with Serious Mental Illness (SMI) are intractably high, representing a serious public health concern and a critical target for interventions. Yet, at present available treatments offer modest benefits. Thus, there remains an urgent need to identify novel approaches to address suicide risk in this population. Previous reports have linked suicide risk with poor social functioning. Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness. Consistent with these findings, individuals with SMI at risk of suicide display social functioning difficulties along with poor emotion awareness (i.e., alexithymia). Employing a proof-of-concept design, the aim of the present study is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention with smartphones designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI. Read Less

The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders. Read Less

This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care. Read Less

Investigators will conduct a confirmatory efficacy trial of Interpersonal and Social Rhythm Therapy (IPSRT) delivered via telehealth for offspring of bipolar parents (OBP; age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference. As clinically indicated, youth are offered Community Treatment Referral (CTR) for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include mania and affective lability. Investigators will also further investigate the hypothesized mechanism underlying IPSRT (i.e., sleep/circadian disruption) across levels of analysis, and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. Investigators will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination. Read Less

The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR). Read Less

This study examines the feasibility and acceptability of a virtual tumor board for cancer and mental illness for patients with serious mental illness and a new cancer diagnosis. The study also examines the impact on patient care, psychiatric symptoms, and clinician self-efficacy in managing this population. Read Less

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication. Read Less

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. Participants who are receiving care at coordinated specialty care (CSC) early psychosis clinics across the United States will be recruited to participate in this study. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training. Read Less

Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and alcohol biosensor technology to investigate responses to alcohol, compared to placebo, and relationship with parental risk for alcohol use disorders and/or bipolar disorder in young adults. Baseline clinical, cognitive, and behavioral assessments will be completed in 100 young adults (21-26 years; 50% women, no history of AUDs>mild). Participants would be equally divided among those with parental history of bipolar disorder but not AUDs, parental history of bipolar disorder and AUDs, parental history of AUDs but not bipolar disorder, and typically developing age- and sex-matched controls with no parental history of mood disorders or AUDs (N=25 per group). Then, while wearing Secure Continuous Remote Alcohol Monitoring [SCRAM] sensors, participants will complete within-person, counter-balanced, beverage sessions (following standard beverage administration procedures) in a simulated bar laboratory. Changes in heart rate, body sway and subjective self-report measurements of intoxication will also be completed while under the influence of alcohol or placebo. Specifically, individual differences in transdermal alcohol concentration (the primary data output from SCRAM sensors), physiological changes (e.g. heart rate), and the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) will be investigated and differences between parental risk subgroups and healthy comparison participants investigated. Differences in transdermal alcohol concentration collected while under the influence of alcohol will be the primary data outcome assessed. Changes in heart rate, body sway, and experience of stimulating, sedative, and anxiolytic effects (from self-report survey data) while under the influence of alcohol compared to placebo session will also be investigated. Additionally, associations between objective and subjective responses to alcohol and drinking patterns will be explored (secondary outcome). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions. Read Less