Active clinical trials for "Bipolar Disorder"

Bipolar Disorder (BD) is a chronic and severe mental illness characterized by the emergence of alternating mood episodes which range from extreme depression to manic states. Beyond affective episodes, there is consensus considering that cognitive and functional impairment are also core features in a substantial proportion of patients suffering from this mental condition, being both of them responsible of a negative impact on perceived quality of life (QoL). Despite, the association between cognitive performance, clinical and functioning outcomes in patients with BD has been largely explored among adult and middle-aged patients, there is a dearth of research about aging process among older adults with bipolar disoder (OABD) as well as in the design of tailored intervention targeting older individuals. Due to the longer life expectancy and subsequent aging of the world's population, is becoming increasingly common that people presenting with chronic health condition, including BD, survives longer. Currently, it has been estimated roughly the 25% of whole BD population is over 60 years old and it is expected that this percentage will increase up to 50% by 2030. Consequently, there is an urgent need not only to explore specific implication in clinical and neurocognitive course and to investigate symptom development throughout this vital stage elder-life phase, but also to design specific interventions aimed to cope with special needs in this specific population.

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.

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) and two different forms of electroconvulsive therapy (ECT) in sustaining response during and after a course of continuation treatment.

This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.

The objective of this study is to compare the efficacy of left unilateral versus bilateral accelerated Theta Burst Stimulation (TBS) in suicidal reduction and in reduction of severity of depressive symptoms in patients with bipolar depression.

Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.

This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up.

The lifetime prevalence of Bipolar II is 0.4% with the time spent with depressive symptoms outnumbering the time spent with hypomanic symptoms by 35 to 1. Regarding current treatment options, psychotherapy is effective for managing depressive symptoms, with CBT being particularly efficacious. Unfortunately, CBT is often not a feasible treatment option. Electronic CBT (e-CBT) is more accessible for treating various mental illnesses with evidence suggesting it can increase treatment adherence and patient satisfaction. Moreover, e-CBT is suggested to have comparable outcomes to in-person CBT in the treatment of depression and anxiety. Typically, patient-clinician interactions of e-CBT are administered through email however, this is an insecure, unsustainable, and non-scalable treatment delivery method. The proposed study will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for the delivery of e-CBT. The aim is to evaluate the feasibility and effectiveness of using OPTT for the treatment of BAD-II with depressive symptoms, while also analyzing social, cultural, and personal factors affecting patients' experience. Participants (n = 80) diagnosed with BAD-II in a depressive episode will be recruited from the Mood and Anxiety Clinic at Providence Care Hospital in Kingston, Ontario, Canada. Eligible participants will then be randomly assigned to either the treatment group (e-CBT plus treatment as usual (TAU)) (n = 40) or the control group (TAU) (n = 40) where they will complete the 12-week program. Participants in the TAU group will be offered the e-CBT program after the first 12 weeks if they wish to take part. Participants in the e-CBT group will complete weekly modules mirroring in-person CBT content and complete homework assignments that will be evaluated by a clinician who will provide personalized feedback through OPTT. Progression/regression of participants will be analyzed using the MADRS, YMRS, and CGI-BP-M questionnaires administered at baseline, after week 6, and after week 12. Personal, social, and cultural factors impacting participant experience will be investigated through an in-depth interview utilizing focus groups. The findings from this study will be the first on the effectiveness of delivering e-CBT to patients with BAD-II with residual depressive symptoms. This approach can provide an innovative method to address the barriers associated with in-person psychotherapy.

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing randomized control trials (RCTs) have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Canadian Rapid Treatment Centre of Excellence), phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe TRBD (type I & II) is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining the between group difference in change from baseline to day 14, using analysis of covariance (ANCOVA), with 14-day MADRS as the outcome and baseline MADRS and stratification variables (sex, bipolar type) as covariates. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects (to day 28).