Active clinical trials for "Bipolar Disorder"

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Background: Community Health Centers care for over 20 million rural, low income and minority Americans every year. Patients often have complex mental health problems such as Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers located in rural areas face substantial challenges to managing these patients due to lack of onsite mental health specialists, stigma and poor geographic access to specialty mental health services in the community. As a consequence, many rural primary care providers feel obligated, yet unprepared, to manage these disorders, and many patients receive inadequate treatment and continue to struggle with their symptoms. While integrated care models and telepsychiatry referral models are both promising approaches to managing patients with complex mental health problems in rural primary care settings, there have been no studies comparing which approach is more effective for which types of patients. Objectives: The central question examined by this study is whether it is better for offsite mental health specialists to support primary care providers' treatment of patients with PTSD and Bipolar Disorder through an integrated care model or to use telemedicine technology to facilitate referrals to offsite mental health specialists. We hypothesize that patients randomized to integrated care will have better outcomes than patients randomized to referral care. Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited from Community Health Centers in three states (Arkansas, Michigan and Washington) and randomized to the integrated care model or the referral model. Patient Outcomes: Telephone surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups. Telephone surveys will measure access to care, therapeutic alliance with providers, patient-centeredness, patient activation, satisfaction with care, appointment attendance, medication adherence, self-reported clinical symptoms, medication side-effects, health related quality of life, and progress towards life goals. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, primary care providers will be invited to participate in qualitative interviews to voice their perspective.

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression. The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.

In this pilot study, we propose to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.

The purpose of this study is to test the efficacy of metformin for treatment antipsychotic-induced metabolic syndrome in bipolar disorder patients.

Patients with severe mental illness (SMI) die younger than persons in the general population. Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient adherence are central problems to reducing cardiovascular risks for patients with SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized controlled trial comparing an initial treatment strategy of free, fixed-doses of two generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental health clinics versus usual treatment. The study will include adult patients (18+ years old) with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six months from within four mental health clinics in the Boston area. We have three aims: 1) to compare the proportions of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for variation in adherence over time, using causal inference techniques to estimate the per-protocol effect of the intervention. Our three aims examine whether this low cost, streamlined treatment strategy increases the numbers of subjects receiving cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12 months, and collect interview and biometric data at baseline and over the following 12 months. Subjects will have the option to continue for another 12 months, during which we will continue to collect interview and biometric data, but will not prescribe cardiovascular medications. This population-based initial treatment strategy could be an effective and efficient approach for overcoming traditional barriers to cardiovascular disease prevention within the SMI population. Findings from this study will inform efforts to improve care and outcomes, and to enhance survival for patients with severe mental illness.

The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating nature, characterized by lifelong recurrent episodes and residual intraepisodic symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have reported dramatic illness-associated morbidity and premature mortality in bipolar patients. The efficacy and safety of antidepressant drug treatment in BD is the subject of long-standing debate based on a scientific literature that is limited and inconsistent. The evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is insufficient evidence for treatment benefits with antidepressants combined with mood stabilizers. The need to develop new agents for the treatment of depression, and in particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In the past years there has been increasing interest in the health benefits of supplemental and/or dietary substances in the treatment and prevention of depression. The disaccharide trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation. In vivo studies with trehalose show cellular and behavioural beneficial effects in animal models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a process that had been recently suggested to be involved in the therapeutic action of antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like properties and that the trehalose induced behavioral changes are possibly related to trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that trehalose also augments lithium effects in animal models (mice). Based on this hypothesis, this project aims to conduct a study to assess the efficacy and tolerability of trehalose as adjunctive treatment to lithium in bipolar depression.

All participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic Han descendants. Participants will be randomly assigned to either the (1) pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals (60-80 participants per group) will be recruited for this study. For each CBGT group, 12-weekly sessions are scheduled according to patients' preference. The investigators will attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy and CBGT for bipolar disorder patients.