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Bipolar Disorder clinical trials

View clinical trials related to Bipolar Disorder.

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NCT ID: NCT04133233 Completed - Bipolar Depression Clinical Trials

Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

DEPIL-2
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse

NCT ID: NCT04121091 Completed - Anhedonia Clinical Trials

Pramipexole to Target "Anhedonic Depression"

PILOT-PRAXOL
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.

NCT ID: NCT04098497 Completed - Bipolar Disorder Clinical Trials

Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3

Start date: September 13, 2019
Phase: Phase 1
Study type: Interventional

This study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. Its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective and evidence-based adaptive intervention. In this aim of the study, investigators will evaluate how individuals with BP respond to a microintervention based in acceptance and commitment therapy (ACT) that is delivered with a mobile app.

NCT ID: NCT04068467 Completed - Schizophrenia Clinical Trials

Evaluation of mHealth for Serious Mental Illness

Start date: January 6, 2020
Phase: N/A
Study type: Interventional

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

NCT ID: NCT04034147 Completed - Bipolar Disorder Clinical Trials

Clinical Determinants of the Discrepancy Between Objective and Subjective Cognition in the Versailles FACE-BD Cohort

METACOG-BD
Start date: January 1, 2009
Phase:
Study type: Observational

Metacognitive abilities have been scarcely investigated in bipolar disorders, with inconsistent results. This may appear somewhat surprising, as metacognitive training is a very promising intervention aiming at improving psychosocial functioning in bipolar disorders. One way to investigate metacognition is to address the discrepancy between objectively measured cognition (through neuropsychological testing) and subjective cognition (through self-reported questionnaire investigating one's perception of cognitive functioning). Objective and subjective cognition are two fundamental determinants of functioning in bipolar disorder. Objectively-measured cognition is directly associated with performance-based functional capacity but not with self-reported or interview-based functional capacity. In contrast, subjectively-measured cognition is associated with self-reported and interview-based functional capacity, but not performance-based functional capacity. Associations between subjective cognitive functioning and neuropsychological performances are usually weak, with a moderating effect of manic and depressive symptoms. Manic symptoms are associated with a decrease in cognitive complains, whereas depressive symptoms are associated with an increase in cognitive complaints. Predictors of the discrepancy between objective and subjective cognition in bipolar disorder are still weakly understood. One study reported that the subjective overestimation of cognitive dysfunctioning was positively predicted by more subsyndromal depressive and manic symptoms, hospitalizations, and BD type II. This study also reported that the subjective overestimation of cognitive dysfunctioning was associated with greater socio-occupational difficulties, more perceived stress, and lower quality of life. However, these previous studies had relatively limited sample sizes (below 150). They also ignored other potential predictors of the discrepancy between objective and subjective cognitions such as psychotic features, impulsiveness, and childhood trauma. Moreover, they also ignored whether this discrepancy was associated with medication adherence. The present study intends to explore the predictors of the discrepancy between objective and subjective cognition in bipolar disorder in a cross-sectional sample of 387 stable outpatients with bipolar disorders (type 1, type 2, not otherwise specified). The second objective is to determine whether the discrepancy between objective and subjective cognition in bipolar disorder predicts functioning, quality of life and medication adherence.

NCT ID: NCT04027933 Completed - Clinical trials for Educational Problems

Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder

Start date: September 28, 2017
Phase: N/A
Study type: Interventional

The study was conducted to determine the effect of the simulation method with the participation of standardized patients towards the patients suffering from bipolar disorder to benefit the education of the psychiatry nursing students. The Research Questions 1. Does the use of simulation training with the standardized patients have any effect on the average scores of the fear and behavioral intentions of the students as they approach patients with bipolar disorder? 2. Does the use of simulation training with the standardized patients have any effect on the average scores of the communication skills assessment scale of the students as they approach patients with bipolar disorder? 3. Does the use of simulation training with the standardized patients have any effect on the average scores of the state and trait anxiety level of the students as they approach patients with bipolar disorder? 4. Does the use of simulation training with the standardized patients have any effect on the average scores of the clinical decision making in the nursing scale of the students as they approach patients with bipolar disorder? 5. Does the use of simulation training with the standardized patients have any effect on the average scores of the self-efficacy - sufficiency scale of the students as they approach patients with bipolar disorder?

NCT ID: NCT04020289 Completed - Bipolar Disorder Clinical Trials

A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for BD, and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.

NCT ID: NCT04011280 Completed - Schizophrenia Clinical Trials

Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

Start date: August 12, 2019
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03965871 Completed - Bipolar Depression Clinical Trials

Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression

Start date: March 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.

NCT ID: NCT03959735 Completed - Schizophrenia Clinical Trials

High Intensity Interval Training in Severe Mental Illness

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff & Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu & Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI. The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups. Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI. Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.