View clinical trials related to Bipolar Depression.
Filter by:The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths. Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours. The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression. A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression will be randomized to these two treatments.
Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar Disorders (BD). Increased levels of circulating proteins known as cytokines that promote inflammation have been consistently reported in individuals with bipolar disorders. A particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines that have been consistently identified across depressive, manic, and euthymic periods. Disturbances in inflammation however, are not seen in all individual with bipolar disorder. Those individuals with signs of inflammation also often present with higher prevalence of medical disorders that are also associated with inflammation. Those individuals with significant signs of inflammation may respond to anti-inflammatory treatments. In this study, individuals with bipolar depression who exhibit signs of high inflammation will be enrolled and treated with either an anti-inflammatory biologic known as infliximab or placebo (saline).
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.
This study will attempt to study the effect of adjunctive chronotherapy (wake therapy, sleep phase advance, and bright light therapy) on acutely depressed inpatients. The investigators will attempt to recruit individuals admitted to the acute inpatient unit and study the results of the treatment on depressive symptoms, and suicidality.
Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and limited, and clinical decision making is less refined. Currently, the investigators are investigating the effects of midday bright light therapy for the treatment of bipolar depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a possible biological mechanism which might explain response to light treatment in depressed bipolar patients.
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers are partially effective in the treatment of depressive phase of the illness, although there are some reports relating to the antidepressant properties of these drugs. Other conventional methods (pharmacological) and non- conventional treatment are not effective or involve risks and side effects. Several studies with Transcranial Magnetic Stimulation (TMS) showed that magnetic stimulation daily over the left prefrontal cortex may improve the mood of patients. TMS is a noninvasive method of stimulating the brain. The instrument used nowadays in local research and application Clinical is a metallic coil formed in figure 8 (coil format 8). This instrument was capable of stimulating only surface areas of the brain, primarily the cerebral cortex, at depths of up to 3 inches below the scalp. From this angle, there is clearly a need for a means of producing magnetic fields which can reach deeper brain areas, such as those involved in mood disorders. TMS has little, if any effect in these brain areas. To this end, new coils, calls "H", that promote the stimulation of deep brain areas were developed in collaboration with the National Institute of Health (NIH) in the USA. This new coil - H1 that will be evaluated in this study has been tested for safety in NIH in 2003 by Dr. Abraham Zangen. Yet there are very few prospective clinical, randomized and controlled trials, on the effects of early and late in clinical-cognitive condition and safety of TMS with H1 coils in treating episodes of bipolar depression. The application of EMT with H1 coils can reach deepest regions of the brain and improve the clinical and cognitive condition of subjects with episodes of bipolar depression, and may be confirmed as a safe and virtually free of side effects. By an absence of treatment actually effective for bipolar depression, this study will show whether there are clinical and cognitive benefits of deep TMS with H1 coil in patients with bipolar depression.