Active clinical trials for "Bipolar Disorder"

The present trial consists of 2 sub-studies that investigate important novel aspects of treatment with erythropoietin (EPO) on cognitive dysfunction in bipolar disorder (BD) and recurrent unipolar depressive disorder (UD) (defined as minimum 2 treatment-requiring depressive episodes). The aims of the trial are three-fold. We aim to investigate the effects of 12 weekly recombinant human EPO infusions on cognition in (i) healthy people with cognitive impairment (substudy 1) and (ii) patients with remitted BD or recurrent UD (substudy 2), and (iii) explore early treatment-associated neural activity changes that may predict subsequent cognitive improvement. It is hypothesized that: i. 12 weekly EPO infusions improve cognition in healthy first-degree relatives and remitted BD patients in comparison with saline. ii. EPO vs. saline-treated participants will display early cognition-related neural activity in the frontal lobes, which will correlate with cognitive improvement.

Approximately 4.1% of the adult US population meets the criteria for SMI, a mental disorder associated with significant functional impairment. Even when effective, pharmacologic and psychological treatments often leave individuals with SMI with residual symptoms, impairment, and at risk for re-hospitalization and suicide. The month following hospitalization is a particularly risky time; thus, augmentation treatments that can speed up improvement during brief hospital stays, as well as provide a bridge to outpatient care are urgently needed. Thus, the investigators propose to develop an augmentation to psychiatric hospital care (called "I-Change") that can be continued at home following discharge. I-Change targets interpretation bias, the tendency to resolve ambiguous situations negatively. Interpretation bias is a well-established cognitive vulnerability for psychopathology and is associated with poor emotion regulation, rumination, symptom severity, and suicidal ideation. For example, in a psychiatric hospital sample, interpretation bias upon admission accounted for 28% of the variance in treatment response, and predicted suicidal ideation at discharge, controlling for ideation at admission. Although some existing treatments target this mechanism, most notably Cognitive Behavioral Therapy (CBT), they require individuals to be able to recognize their automatic interpretations and use complex techniques to reappraise them. Individuals with SMI who are experiencing symptoms acute enough to require hospitalization are often treatment refractory and may experience particular difficulty applying these techniques. It is therefore critical to more efficiently and effectively engage this target. Over the past 14 years, the Principal Investigator has developed and validated a training task that utilizes repetition and feedback to reinforce a healthier interpretive style. The computer-delivered version of the task was acceptable to an SMI population and led to better treatment response than a placebo task in patients who exhibited interpretation bias at baseline. The investigators seek to develop this task into a personalized smart-phone delivered intervention. The investigators will harness smart-phone technology to enhance skill acquisition and generalization by improving user engagement and prompting participants to complete a session at set times to ensure adequate dosage and spacing of sessions. The investigators will conduct an open trial (n = 16) and a randomized controlled trial (n = 64) to confirm target engagement (improvement in interpretation bias), evaluate the feasibility and acceptability of delivering I-Change during and following discharge from a partial hospital, and examine clinical outcomes (global improvement, functioning) related to changes in interpretation. I-Change is expected to shift interpretation bias, be acceptable to patients with SMI, and lead to greater global improvement compared to a Symptom Tracking control. Results will support a fully-powered effectiveness trial.

The overall aim of this study is to test the effect of academic detailing (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.

A randomized single-blinded prospective study to evaluate the efficacy of an individualized supervised 8-week exercise program in subjects with moderate to severe depressive episodes compared to treatment-as-usual

Bipolar disorder patients frequently presents recurring episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in the functioning with a low quality of life, relapses of disease and recurring hospitalization. Early diagnosis and appropriate intervention may play a role in preventing the neuroprogressive course of bipolar illness. The new technologies represent an opportunity to develop psychological standardized treatments using internet devices that minimizing the limitations of face to face treatments because of its accessibility that allow adjusting to the availability of each user. However, although exist many online psychological programs through web and mobile devices for bipolar disorder, there is not evidence about their efficacy and effectiveness due to the variability in measures and methodology used.

Depressive episode of bipolar disorder is often the first symptom of patients with bipolar disorder, which is characterized by frequent recurrence, relatively long duration, high comorbidity rate and high fatality rate. People with bipolar disorder spend a third of their lives depressed, and it is these depressive symptoms that lead to long-term disability and early death. The treatment of bipolar depression is controversial. The latest Mood Disorders CPG guidelines recommend first-line therapy: quetiapine, lurasidone, lithium, valproate, lamotrigine monotherapy or combination of quetiapine, lurasidone plus Mood stabilizer, olanzapine plus fluoxetine therapy. In addition, the use of antidepressants is still controversial, and their efficacy, prognosis and risk of mania remain to be evaluated. Vortioxetine is a novel antidepressant with unique characteristics, and its multi-mode mechanism of action can be used to treat a wide spectrum of symptoms of depression. Current clinical experience suggests that the clinical conversion rate of vortioxetine is low, and the depressive symptoms and cognitive symptoms of people with depressive episodes are significantly improved. As of September 2019, a total of 4.87 million patient years (nearly 3 months of treatment with 20 million patients) were treated with vortioxetine in PSUR (Periodic Safety Update), with 51 reported cases of hypomania and 322 reported cases of mania. Based on the above data, the post-marketing conversion rate of vortioxetine is approximately 1 in 10,000 patient-years or 1 in 40,000 patients. Therefore, the efficacy and risk of transferring to mania of vortioxetine in bipolar II depressive episode deserve further investigation.

SABR (from the Urdu word for patience) is a 5-year natural history, longitudinal, prospective study of a cohort of 6,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to antidepressant treatment response (remission, recurrence, relapse and individual outcomes in depressive disorders) and resilience. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters - socio-demographic (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of developing the most robust predictive models of depression treatment response and of outcomes.

Given the phenotypic heterogeneity of bipolar disorder, it seems essential to propose new methodologies to improve the stratification of this pathology in order to describe more homogeneous groups of patients. In this perspective, the neurodevelopmental hypothesis of bipolar disorder seems promising. Brain sulcation is an indirect marker of neurodevelopmental processes. The objective of the study is to highlight sulcal variations between a group of bipolar patients with a neurodevelopmental phenotype (ND) and a group of bipolar subjects without a ND phenotype. A sulcation marker (GPR56) will also be measured from patient blood samples. In order to carry out this project we would like to include 120 participants for a period of 12 months.

The present study is a randomized controlled trial comparing the efficacy and acceptability of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood or psychotic disorder onset or relapse. Young people (ages 13-24) are provided with targeted psychoeducation and learn a variety of coping skills and wellness practices for mood regulation and stress and distress management. Parents meet separately to learn the same skills and receive guidance in supporting their youth with skill development. The therapy is also augmented by a mobile phone application that supports regular symptom monitoring and skills practice.

Fifteen minutes is the typical length of an outpatient medication management appointment for people with serious mental health conditions. These brief interactions with prescribers are frequently provider-driven with insufficient time focused on the patient's needs and personal recovery. Shared decision making is a strategy that could improve this interaction. This study examines how technology can be used in the care process to amplify the voice of the patient, support shared decisions, and improve treatment outcomes. Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on two primary patient-centered outcomes: the patient experience of care with medication treatment and the level of shared decision making. Investigators hypothesize that: Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care. The study team will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires, and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. Investigators are especially interested to learn if and how these two approaches are perceived to change medication treatment, if patients are more satisfied and empowered in their care, and why and how providers perceive and adopt changes to their clinical care.