Active clinical trials for "Bipolar Disorder"

This study will investigate the effect of Repetitive transcranial magnetic stimulation (rTMS) on cognition and long-term clinical outcomes of bipolar patients.

To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.

LiveWell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes.

Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country. Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital. Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level. Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization. Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.

Many patients with depression do not respond well to medication and are diagnosed with treatment refractory depression (TRD). Sometimes medications don't work because an individual metabolizes the drugs in an atypical manner (too fast/slow). Alternatively, drugs may fail to work because the underlying sub-type of depression is not effectively targeted by a medication. This study will use genetic testing of subjects with TRD to personalize the drug treatment of depression and guide the patient to a better clinical outcome. In the guided group, the clinician will receive a pharmacogenetic report to help individually tailor medication selection for TRD patients, potentially allowing the clinician to pick more effective medications right away, and when necessary, use drug combinations that are well-tolerated and less likely to cause unwanted side effects. The control group will receive a sham genetic report and be treated according to typical standards of care. The investigators will conduct our study in a "real world" setting, with few restrictions on which TRD patients can participate. In this way, the findings may be more likely to reveal how useful genetic testing will be when applied more broadly in psychiatry.

This study aims to adapt and apply a psychological program aimed at improving cognitive reserve (CR) in bipolar patients who have recently presented a first episode of the illness. The purpose of this project is to test both the effectiveness of the psychological intervention as well as the stability of the obtained results after nine months of follow-up. One-hundred and twenty patients (60 patients each centre) will be recruited and assessed with clinical, functioning, quality of life, neuropsychological and RC assessment tools. Then, participants will be randomly assigned to two different conditions: the experimental one, consisting in the implementation of the psychological intervention aiming at improving CR (n=60), and the control one, in which the usual pharmacological treatment will be carried on (n=60). Once the psychological intervention has finished (3 months) re-assessment of all the explored variables at baseline will be performed. Finally, after 12 months from the baseline visit, a re-assessment of all the participants in the study will be carried out to verify that post-intervention obtained results remain stable throughout the complete follow-up period. The investigators hypothesized that patients with a recent first episode who have undergone the intervention program will improve their CR as well as measures related to the severity of the difficulties observed at baseline concerning clinical, functioning, quality of life and neurocognitive performance. A second hypotheses is that all these changes will remain stable after nine month follow-up.

Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display greater efficacy as compared to placebo in decreasing body weight in patients with BP who are obese or overweight. To prove this hypothesis, investigators will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP. The investigators have chosen BP rather than another SMI because it is the most common SMI (more common than schizophrenia or schizoaffective disorder) and has a particularly strong association with obesity.

The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.

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).

Cognitive deficits are a core feature across disparate brain disorders, being highly prevalent and pervasive. Impairments in executive function are one of the most consistent findings in clinical and meta-analytical studies and were reported to be a principal mediator of psychosocial impairment and disability. Cognitive dysfunction is thought to be underlied by abnormalities in distributed brain circuits, at the cellular and molecular levels. Nonetheless, the neural mechanisms underlying the dysregulation in these circuits are poorly understood. Emerging evidence indicates that metabolic abnormalities are highly relevant for the domain of cognitive function and indicate that alterations in metabolic pathways may be relevant to neurocognitive decline across different populations. The incretin glucagon-like peptide-1 (GLP-1) is a hormone secreted by intestinal epithelial cells. GLP-1 receptors are widely expressed in the central nervous systems. Pre-clinical trials have demonstrated significant neuroprotective effects of GLP-1. Ongoing clinical trials measuring cognition and mood in populations with various psychiatric disorders lend further impetus to explore the effects of GLP-1R agonists on brain structure and cognitive function. We hypothesize that GLP-1 and the GLP-1R are relevant for molecular and cellular processes that are thought to underlie the formation and maintenance of brain circuits. A derivative of this hypothesis is that the administration of GLP-1 agonists may result in enhanced neuronal survival and consequential increase in gray matter volume. We therefore propose to explore the cellular and molecular abnormalities within and between neural circuits subserving cognition using the GLP-1R agonist liraglutide. The overall goal of this study is to explore the relationship between a metabolic molecular target (i.e. the GLP1 system), the neural circuits of interest and the behavioral phenotype cognitive function.