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Bipolar Depression clinical trials

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NCT ID: NCT06369805 Completed - Bipolar Disorder Clinical Trials

EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION

Start date: June 2, 2021
Phase:
Study type: Observational

This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.

NCT ID: NCT05683431 Completed - Bipolar Disorder Clinical Trials

Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS)

BRAINS
Start date: March 22, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder. The intervention consists of game-like exercises that involve the 'Cognitive Control of Emotion (CCE) - i.e. the ability to control the influence of emotional information on behavior. Deficits in the cognitive control of emotion are a central feature of Bipolar Disorder that contributes to emotion dysregulation, maladaptive mood episodes, and, ultimately, the overall chronicity and severity of illness. Neuroimaging studies of bipolar patients demonstrate neural abnormalities in brain systems involved in cognitive control and emotion processing. Furthermore, these abnormalities predict mood and behavior problems associated with cognitive control of emotion, such as emotion lability, disinhibited behavior, and extreme mood states. The aim of this study is to determine feasibility and examine whether a computer-based program of progressively difficult cognitive control emotion exercises will improve cognitive control of emotion skills and, thereby, result in better emotion regulation and daily functioning in young adults with bipolar disorder. To test the intervention, a single group of young adults (18-30 years old) with Bipolar I Disorder will complete behavioral assessments before and after 20 hours (4 weeks) of CCE training. In order to identify baseline deficits associated with bipolar disorder, a comparison group of healthy young adults will complete behavioral assessments at a single time-point (without CCE training).

NCT ID: NCT05481957 Completed - Bipolar Depression Clinical Trials

Vortioxetine Adjunctive Treatment in Bipolar Depression

Vortioxetine
Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05375214 Completed - Bipolar Depression Clinical Trials

iTBS in Bipolar I Depression

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with treatment response.

NCT ID: NCT05228457 Completed - Clinical trials for Treatment Resistant Depression

Intensive TMS for Bipolar Depression

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.

NCT ID: NCT04471454 Completed - Bipolar Depression Clinical Trials

Verification of the Reliability and Validity of THINC-it Tool in Bipolar Depression

Start date: July 5, 2020
Phase:
Study type: Observational

There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear. The purpose of this study is to verify the reliability and validity of THINC-it cognitive test in bipolar depression, and to further explore the difference of cognitive impairment between attack and remission of bipolar depression, so as to provide empirical research basis for clinical evaluation-based treatment.

NCT ID: NCT04427137 Completed - Bipolar Depression Clinical Trials

Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic

Start date: June 9, 2020
Phase: N/A
Study type: Interventional

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

NCT ID: NCT04420793 Completed - Bipolar Depression Clinical Trials

Voice Changes During ECT

VAPRE
Start date: November 7, 2019
Phase:
Study type: Observational

Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.

NCT ID: NCT04417049 Completed - Bipolar Depression Clinical Trials

Treatment of Bipolar Depression With Pentoxifylline

PTX-BD
Start date: July 12, 2021
Phase: Early Phase 1
Study type: Interventional

Growing theoretical and clinical evidence has suggested that pentoxifylline may have an effect in improving depressive symptoms. Herein, we aim to evaluate the effect of pentoxifylline in patients with bipolar depression over an 8-week trial.

NCT ID: NCT04285515 Completed - Clinical trials for Major Depressive Disorder

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Start date: February 27, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.