Active clinical trials for "Bipolar Disorder"

Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar Disorders (BD). Increased levels of circulating proteins known as cytokines that promote inflammation have been consistently reported in individuals with bipolar disorders. A particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines that have been consistently identified across depressive, manic, and euthymic periods. Disturbances in inflammation however, are not seen in all individual with bipolar disorder. Those individuals with signs of inflammation also often present with higher prevalence of medical disorders that are also associated with inflammation. Those individuals with significant signs of inflammation may respond to anti-inflammatory treatments. In this study, individuals with bipolar depression who exhibit signs of high inflammation will be enrolled and treated with either an anti-inflammatory biologic known as infliximab or placebo (saline).

This pilot effectiveness trial will evaluate the feasibility, acceptability, and effectiveness of a structured peer support program based on the Certified Peer Specialist Program of the Depression and Bipolar Support Alliance (DBSA).

This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.

Bipolar Disorder (BD) (previously known as "manic depression") is a severe mental health illness affecting at least 1% of the population and with annual NHS cost estimated at £342 million. It is characterised by alternating episodes of acute mood swings: depression and "mania" (mood elation). BD also comes with less severe mood swings we call "mood instability", and ongoing high levels of anxiety that impair well-being even during periods between the acute mood breakdowns. Anxiety and mood instability are associated with worse outcome of the disorder. All these symptoms can be accompanied by the presence of troublesome mental images (e.g. seeing a memory in the mind's eye) such as intrusive "flashbacks" of negative past events. Recent studies suggest that individuals with BD experience more vivid, compelling and upsetting mental images compared to other patient groups and this could contribute to their clinical difficulties. Cognitive Behavioural Therapy (CBT) is a well established and successful psychological therapy used in the National Health Service (NHS), UK but as yet with limited efficacy in BD. Targeting mental imagery has long been part of general CBT. In particular, imagery-based treatment techniques have proved successful in anxiety disorders, but have not been brought to CBT for Bipolar Disorder yet. Our study Mood Action Psychology Programme (MAPP) investigates the delivery of a brief imagery-focused cognitive therapy (imCT) intervention to people with BD, studying a series of patients in detail one by one a "case series"). We offer a structured and individualised psychological treatment in line with the aims of NHS guidelines. The imCT protocol has been successfully delivered and audited in our psychological service in Oxford (OxMAPP). The proposed MAPP study aims to formally assess for the first time the effectiveness of imCT. In particular we hypothesise that imCT via the Mood Action Psychology Programme (MAPP) will result in (i) reduced levels of anxiety and (ii) reduced levels of low mood after treatment compared to baseline (both measured over 4 weeks) in individuals with BD. Overall, this works aims to contribute to improved psychological treatment for BD.

The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive behavioral intervention for serious mental illness (SMI) and to identify the facilitators, barriers, and costs of implementation. We would like to determine whether the addition of a mobile phone monitoring software program to a brief behavioral intervention for bipolar disorder or schizophrenia improves symptoms arising from the disorders. In this study we will be assessing the feasibility, acceptability and short term effect of the mobile phone enhanced intervention for bipolar disorder and schizophrenia.

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment. Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms. In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.

This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep phase advance, and bright light therapy) on acutely depressed inpatients. The investigators will attempt to recruit individuals admitted to the acute inpatient unit and study the results of the treatment on depressive symptoms, and suicidality.

Non-invasive brain stimulation therapies have been increasingly investigated in recent years as a treatment for neuropsychiatric disorders, particularly mood disorders. They are particularly appealing since many patients are either refractory or present side effects to standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel non- pharmacological brain stimulation technique, might help in overcoming some of these issues, since it has low cost, high portability and it is relatively easy to use. TDCS consists in applying a weak, direct current through two electrodes placed over the scalp; the anode and the cathode increasing and decreasing cortical excitability during and beyond the period of stimulation. It is also a safe technique with only mild adverse effects described. Previous studies, some of them from our group, have described that tDCS is an effective technique for major depression. However, the role of tDCS as a treatment for bipolar depression (BD) has been insufficiently investigated. Therefore, our aim is to address the antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in a refractory sample.

The aim of the study is to examine whether determining treatment strategies based upon Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome in patients with psychosis. The investigators predict that prospectively testing CYP2D6 genotype and using this information to treat psychotic patients with risperidone will improve clinical outcomes. Specifically, CYP2D6 poor metabolizers who are treated with low dose and slow titration of risperidone will do better than those who are treated with usual dose and titration approach in terms of rates of side effects and clinical improvement.

In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group.