Active clinical trials for "Bipolar Disorder"

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).

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.

The goal of this clinical trial is to investigate the effect of a four-weeks, intensive virtual reality (VR)-based cognitive remediation (training) programme involving simulated daily-life challenges on cognition and functional capacity in symptomatically stable patients with mood disorders (depression or bipolar disorder) or psychosis spectrum disorders (F20-F29; e.g. schizophrenia or schizotypal disorder). The investigators hypothesize that VR-based cognitive remediation vs. a VR control treatment has a beneficial effect on cognition after four-weeks treatment completion (primary outcome assessement time) measured with a novel ecologically valid VR test of daily-life cognitive functions (The CAVIR test; primary outcome measure), a verbal learning and memory composite score based on a traditional neuropsychological test and a performance-based measure of daily functioning (secondary outcome measures). Finally, for exploratory purposes, the study will examine neuronal underpinnings of treatment effects, and effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes).

Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.

The purpose of this study is to determine the effectiveness of MST in bipolar depression and to compare the side effects of magnetic seizure therapy (MST) and electroconvulsive therapy (ECT)

Mood disorders including bipolar disorder and depression are common disabling disorders with depression affecting 11.2 to 16.0% of the general population and the lifetime prevalence of bipolar disorders at an estimated 4.4%. Although treatment with antidepressants medications is common and effective in some patients, 42.7% of patients show inadequate response to treatment with antidepressants and a large proportion (55.3%) continue to have ongoing depressive symptoms. Psychological and behavioural interventions such as cognitive behavioural therapy (CBT) and behavioural activation (BA) are effective treatment for depression alone or in combination with antidepressants. Depression can also occur in the context of bipolar disorder which is characterized by recurrent episodes of depression and mania (DSM-5). The depressive episodes within bipolar disorder may be similar to depressive disorder, however the management of these episodes is fraught with the challenge that antidepressant pharmacotherapy may precipitate manic episodes and lead to further destabilization of bipolar disorder. Therefore, an alternative to antidepressants and additional therapies are needed to support patients' recovery and mood stability, as well as to achieve better treatment response and remission. BA is not currently available in a structured format and has not been tested for its effectiveness in bipolar disorders in a specialized hospital-based program. The evidence for BA has been investigated in depression however the evidence for bipolar disorder is lacking, therefore this study aims to assess the effectiveness of BA as treatment for bipolar disorder.

The purpose of this clinical trial is to measure the safety and effectiveness of a non-invasive brain stimulation device called Transcranial Alternating Current Stimulation (tACS) in participants with bipolar disorder (BD). Participants will be asked to come in for 3 sessions. If participants qualify at the screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well as have a 30-day follow-up phone call.

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.

A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with treatment response.

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.