View clinical trials related to Major Depressive Disorder.
Filter by:Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression. Microglia activation can lead to an increase in the levels of proinflammatory cytokines, including TNF-α, which leads to neuronal apoptosis in the specific neural circuits of some brain regions, abnormal cognition, and treatment-resistant depression (TRD). Protein kinase C (PKC) is a key regulator of the microglia activation process. The investigators assume that the abnormality in PKC might be the serum biomarkers of depression.
Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) targeted to striatal and surrounding capsular areas in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed, with one showing a large difference between active and sham DBS and another finding no difference. Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life,neuropsychological and neuroimaging measures, and finding predictors of response.
This is a retrospective registration. The study was conducted at The Ohio State University from 2011 to 2012. This study was approved by an Institutional Review Board at The Ohio State University. The investigators retroactively registered this trial to facilitate publishing results in journal that now require registration. Any reference to the study's registration will make it clear that the registration was retroactive. Cognitive behavior therapy (CBT) has been shown to be an effective treatment for depression. However, a substantial number of patients do not respond to treatment or continue to be symptomatic at its conclusion. An important goal of ongoing research is to find ways to enhance treatment outcomes. One approach to doing this is to modifying existing treatments to individualize the approach to better meet the needs of individual patients. In this study, the investigators tested two main components of CBT to empirically evaluate patient characteristics that may predict differential response to these components. By using components of CBT, any suggestions about the strategies that are best suited to different patients are likely be easily implemented by therapists providing CBT. The two treatment components the investigators examined were: cognitive interventions (e.g., challenging negative automatic thoughts) and behavioral interventions (e.g., engaging in activities to promote a sense of pleasure or accomplishment). The investigators recruited adults with major depressive disorder and randomized them to a cognitive or behavioral intervention. After 8 weeks of treatment, patients were randomized again to a cognitive or behavioral intervention. Consequently, participants were offered a total of 16 weeks of treatment. Depressive symptoms were assessed with the Beck Depression Inventory-II (BDI-II) and the Hamilton Rating Scale for Depression (HRSD), with the latter being the primary outcome measure. Several variables that might serve to predict differential response to cognitive and behavioral treatments were also assessed. The results of this study may help to elucidate how cognitive or behavioral interventions might be selected so as to enhance overall treatment outcomes.
Major depressive disorder (MDD) characterized by high prevalence, high recurrence rate and high disability rate is a mental illness with the heaviest burden and has become a major public health issue in China and the world. Great challenges in diagnosis and treatment of depression consist of the complicated pathogenesis, a lack of objective diagnostic criteria, unsatisfactory treatment outcomes and poor treatment compliance. The previous studies of our research team showed that depression is affected by multiple factors. We could explore important markers for the diagnosis, treatment and prediction of treatment efficacy in depressed patients' data collected from different dimensions including immunometabolism, brain electrophysiology, brain structure and functional neural circuits, neuropsychology and psychophysiology. Our completed studies in the National Science and Technology Support Program and National Key Research and Development (R&D) Program of the 12th and 13th Five-Year Plan in China found that treatment designed for specific clinical subtypes can improve the treatment effect, and meanwhile, the application of electronic-measurement based care (e-MBC) combined with smart mobile terminals can effectively provide whole-course medical management for patients, improve patient compliance and increase the efficacy of clinical diagnosis and treatment. However, due to disease diagnosis based on clinical symptomatology without subtype distinction and lack of multi-scale biological data mining, multidimensional assessment and deep integration, the results of most previous studies can hardly be used in clinical practice. Therefore, there is a strong urge to carry out a systematic research in which multidimensional evaluation of clinical characteristics and a large scale of data collection and mining are needed to form clinical diagnosis and optimal treatment regimens for depression subtypes. To achieve the goal, patients with depression will be our research subject in this study. First, on the basis of the previous cohort study and the whole-course e-MBC, patients' data of movement, respiratory rate, heart rate and sleep will be further collected. With the help of artificial intelligence (AI) technology such as deep machine learning, the data integrated with EEG imaging and specific immunometabolic markers in blood will be analyzed with clinical characteristics. The model of diagnosis and classification will be established based on multidimensional clinical assessment and verified. Second, through a prospective multicenter randomized controlled trial, optimal treatment regimens for different depression subtypes and individualized magnetic stimulation physical intervention technology navigated by AI will be explored so as to establish a predictive model of curative effect. Finally, long-term follow-up and its regular data collection can be completed on the patient diagnosis and treatment platform which is linked to the e-MBC. Thus, a stable clinical cohort and an advanced database containing multidimensional information of depression will be set up. The whole course e-MBC management platform will be optimized and promoted to improve patient compliance, treatment efficiency and prognosis. This study can provide evidence for precise diagnosis and classification of depression and optimal treatment regimens for different subtypes.
Repetitive transcranial magnetic stimulation (rTMS) with theta bursts (i.e. TBS) of the dorsolateral prefrontal cortex (DLPFC) is an innovative treatment for major depressive disorder (MDD). Indeed, the U. S. Food and Drug Administration (FDA) has only recently approved TBS (in August 2018). However, fewer than 50% of patients show sufficient response to this treatment; markers for response prediction are urgently needed. Moreover, there is a lack of knowledge of the mechanism of action of TBS of the DLPFC. This is due to difficulties of directly measuring prefrontal stimulation effects, as compared to the stimulation of motor cortex and utilizing motor evoked potentials as direct readout. However, knowledge of immediate DLPFC modulation by TBS is necessary to extrapolate downstream effects on the neural and symptoms level. Thus, there is a need for research that aims to quantify the direct and immediate after-effects of TBS on DLPFC function. Most importantly, with regard to precision medicine, there is a need for research that explores the utility of immediate DLPFC reactivity to TBS for the prediction of antidepressant treatment response. There is common agreement that certain forms of rTMS inhibit or excite brain activity, respectively. However, evidence indicates that there is considerable individual variability in the brain responses to rTMS. Whether differences in individual DLPFC modulation by rTMS can be utilized as a predictive marker for treatment response remains to be investigated. This research program will exploit the combination of functional near-infrared spectroscopy (fNIRS) with brain stimulation. Concurrent TBS/fNIRS measurements will allow us to systematically investigate TBS-induced modulation of blood oxygenation as a proxy for induced brain activity changes. The findings from this study will (1) elucidate the immediate effects of excitatory and inhibitory TBS on prefrontal activity in TBS treatment-naïve patients with MDD and (2) validate the potential utility of TBS-induced brain modulation at baseline for the prediction of antidepressant response to four weeks of daily TBS treatment. Major depression is a severe mental disorder and is associated with considerable economic costs but adequate treatments are poorly explored. This research program will pave the way towards an affordable and easy-to-implement method for response prediction before treatment commencement. Thus, our research proposal has high potential to inform tailored treatment strategies, as envisaged in precision medicine.
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.
This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.
This study analyzes the affects or Adderall extended-release (XR) in Subjects receiving brain stimulation therapy for the treatment of Major Depressive Disorder. Subjects will be assigned by chance to active or placebo group. Active group will be asked to take one 15 mg pill once daily of Adderall XR (amphetamine) and the Placebo group will be asked take an identical appearing tablet/capsule, one tablet by mouth daily. The placebo tablet has no active ingredients and has no affect on the body or mind. With the exception of the study drug, all other study activities between both groups will be identical. Subjects will use the assigned study drug two weeks before therapy and throughout the first 10 therapy treatments. A total of seven(7) visits will be required for screening, drug assignment, and completion of mood assessments. This study will enroll a total of 30 Subjects.
Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective antidepressant. Investigators will address these questions in a two-part randomized double blind exploratory clinical trial. For this part of the study, investigators will determine relationships between target engagement and clinical outcomes (mood) and functional sub-constructs of cognitive control and emotion negativity bias, and whether imaging markers at baseline predict changes in antidepressant response. One hundred people with depression (50 in each group) will be randomized to receive either HD-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham HD-tDCS in the MRI scanner, which will allow investigators to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests.