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143 active trials for Bipolar Disorder

A Trial of Functional Remediation in Patients With Bipolar Disorder

In the last decade several evidences show that cognitive impairment is a major feature of bipolar disorder (BD), that is strongly associated with patients' functional outcome. The most affected cognitive domains in BD are attention, memory and executive functions. BD represents a mental illness of considerable therapeutic complexity and the fight against cognitive and functional deterioration have contributed to increase the interest in the development of specific therapeutic strategies.There is the need of new non-pharmacological interventions in BD in order to improve not only affective symptoms, but also cognitive dysfunctions, with the final goal to achieve full functional recovery. The present study is focused on Functional Remediation (FR), a novel group intervention created by the Bipolar Disorder Unit of the Hospital Clinic of Barcelona and designed specifically for bipolar patients, based on a neuro-cognitive-behavioural approach. It involves neurocognitive and psychoeducation techniques (21 weekly sessions). The present study aims to assess FR efficacy in improving cognitive deficits and psychosocial functioning in a sample of euthymic patients with BD, compared to standard treatment (TAU). This is a randomized and rater-blind trial, involving 54 adult out-patients diagnosed with BD I or II (DSM-5 criteria) and clinically stable for at least two months. Patients will be assessed at baseline, post-treatment and 6-months follow-up, on validated cognitive, clinical and functional rating scales. The main result expected is that patients receiving FR will show better cognitive and psychosocial performance, further confirming the preliminary evidence on the utility of FR as an element of standard care for BD patients.

Start: January 2021

Self and Body-esteem in Socio-professional Rehabilitation

The body esteem influences the physical appearance, which can be a social brake. To enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. The study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center

Start: June 2020

Lifestyle Intervention for Young Adults With Serious Mental Illness

This is a four year project evaluating the effectiveness of a group-based lifestyle intervention (PeerFIT) supported by mobile health (mHealth) technology and social media compared to Basic Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in achieving clinically significant improvements in weight loss and cardiorespiratory fitness in young adults with serious mental illness (SMI).

Start: July 2017

Antidepressant Treatments and Cognitive Function of Bipolar Patients

Patients with bipolar disorder (BD) have a wide range of neurocognitive dysfunction, which lead to impaired psychosocial function and reduced quality of life. Therefore, improving neurocognitive function has become an important goal of BD treatment. Aiming at this, some clinical studies have been performed but failed to illustrate significant positive efficacies of pharmacological therapy or non-pharmacological therapy, which could attribute in part to insufficient understanding on the risk factors that affect the neurocognitive function of BD patients. Delayed diagnosis of BD is so common that a lot of patients receive long-term antidepressant treatment before of diagnosis of unipolar depression. There is controversy about whether antidepressant treatment in early stage would affect the neurocognitive function of BD patients. In view of the high prevalence of delayed diagnosis and the use of antidepressants, it is of great scientific significance and clinical value to clarify this matter and other factors that may potentially affect the neurocognitive function of BD patients.

Start: July 2020

ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.

Start: September 2020

Emotional Proactive Processing in Bipolar Disorder

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

Start: October 2020

Cognitive Stimulation for Elderly Bipolar Patients

Age is a major risk factor for the development of cognitive disorders and neurodegenerative pathologies. Cognitive disorders during the phases of bipolar disease are known to exist, and alterations increase significantly after the age of 65. Drug treatments seem to have only a limited effect. A cognitive stimulation program has proven his benefit to patients over 65 with neurodegenerative diseases (Israel, 2004). We propose to evaluate this cognitive stimulation program that we have adapted to bipolar disease.

Start: September 2020

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

Start: July 2019

Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)

This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved.

Start: November 2019

Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials

Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization is a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania. The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region of Denmark are invited to participate. Patients are at discharge from the psychiatric hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial consists of two separate trials according to diagnosis, bipolar disorder or unipolar disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).

Start: May 2017

Emotion Recognition Modification for Bipolar Disorder

Previous research suggests that people with bipolar disorder have trouble accurately identifying emotions. The goal of this study is to test a novel intervention, emotion recognition modification (ERM), to help improve the ability of young people with bipolar disorder to identify emotions.

Start: October 2014

Reward and Punishment Sensitivity in Bipolar Disorders

Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors. While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers. This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls

Start: February 2020

Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

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), alone or in combination with practical support from a community health worker, on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI). Further, this study will determine if these interventions improve smoking cessation rates for adults with SMI who smoke.

Start: July 2016

Evaluation of mHealth for Serious Mental Illness

This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.

Start: January 2020

Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)

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.

Start: April 2017

Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.

Start: March 2017

Virtual Reality Job Interview Training in Severe Mental Illness

This is a randomized controlled trial to evaluate the community-based effectiveness of virtual reality job interview training (VR-JIT). Northwestern University is partnering with Thresholds Inc. to evaluate the effectiveness of VR-JIT at improving interviewing skills and access to employment. In addition, we will evaluate the cost effectiveness of VR-JIT and the process for implementing VR-JIT at Thresholds.

Start: June 2017

Validation of a Cognitive Remediation Program for Bipolar Disorders

This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

Start: February 2014

Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.

Start: February 2015

The Gut Microbiota of Bipolar and Depression

Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for relationships with symptoms. Methods: Investigators prospect to recruit subjects including patients and controls amount to 240. All subjects will be collected for blood and stool samples,assessed by clinical scales. Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and clinical scales to obtain the possible interaction between diseases and gut microbiota.

Start: January 2020