View clinical trials related to Bipolar Depression.
Filter by:Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.
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.
The PWECT015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ECT). Subjects will be compared both within groups and in-group via psychometric scales.
The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of repetitive 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 (BPD) who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. To facilitate the development of rTMS protocols there is a need for biomarkers that are sensitive to BPD symptom severity and clinical improvement. Previously in our lab, investigators developed biomarkers suitable for depression trials, and these biomarkers are very likely to show sensitivity to BPD, since they are associated with brain regions and functions associated with BPD. As a secondary aim, the investigators will try to identify biomarkers in cortical region associated with BPD, and formulate a statistical model that may be able to predict BPD remission after the treatment. this study will lead to development of new brain stimulation treatment protocols and biomarkers, will aid in treatment selection, and eventually lead to better clinical outcome for patients suffering from BPD.
Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) in patients with unipolar disorder and bipolar disorder.
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.
This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.
Hypothesis: the hypothesis of the study is that aerobic physical exercise (PE) performed with the method Braining accelerates recovery from bipolar depression as well as improves psychiatric and somatic health in individuals with bipolar depression Method: a randomized controlled trial with 54 patients with bipolar depression are randomized to 6 weeks of either 1) supervised aerobic PE 3 times/week, 2) supervised relaxation/stretching 3 times/week or 3) information about PE but no supervised activity.
Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing RCTs have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder depression (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of repeated sub-anesthetic maintenance doses of IV ketamine in, over a period of twelve weeks. Open-label ketamine infusions will be provided on a flexible schedule (every 2-4 weeks) with flexible dosing (0.5-1.0mg/kg over 40 minutes) titrated to optimize benefits, while minimizing the dosage and frequency over a 12-week extension period. All patients participating in this open-label study will have completed an acute course of infusions in a parent two-site, phase II, double-blinded midazolam-controlled RCT trial. In addition to this acute course of four infusions, a maximum of six infusions will be provided over the 12-week period. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Canadian Rapid Treatment Centre of Excellence), single-arm, open label, 12-week extension trial evaluating the effects of flexibly-dosed adjunctive ketamine infusions for TRBD to maintain antidepressant effects in participants who achieved an antidepressant response (MADRS decrease by >50%) or remission (MADRS < 12) following an acute course of four ketamine infusions is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining by a linear mixed model from baseline to week 12. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects.
An explorative, open label, single armed, flexible dose, single center, phase IIa study of 8 weeks, initiated in inpatients with bipolar depression. The study will consist of 9 visits and 1 safety visit. Inpatients with a primary diagnosis of bipolar disorder (type 1 or 2) currently in an acute depressive phase (i.e. bipolar depression) and being on stable medication with at least one mood stabilizer.