View clinical trials related to Depressive Disorder, Major.
Filter by:Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets formulation is proposed for marketing approval in China for same indication. Therefore, a pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label, single-centre and single cycle study to evaluate the pharmacokinetics, safety and tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses. Approximately 16 males and females Chinese healthy subjects will be enrolled into the study to get 12 completed subjects.
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact. Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication. In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity. Participants in this study will undertake 30 minutes of daily music intervention self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess depression symptoms, sleep quality, quality of life, and brain activity pre- and post-treatment. The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of mood disorders, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.
The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
Major depressive disorder (MDD) is a debilitating illness that affects millions of individuals in North America and can result in clinical symptoms including loss of pleasure and feelings of worthlessness, in addition to significant cognitive impairments (e.g., memory, attention) that affect daily functioning. Major depression bears a heavy burden for the individuals and family members afflicted, as well as an enormous health care and economic cost. Approximately half of major depressive patients seek out treatment for their illness and only 20% of those individuals report their treatment as satisfactory. Many MDD patients do not respond to pharmacological therapy following the first course of treatment, resulting in the need for alternative measures to alleviate the clinical and cognitive symptoms of treatment-resistant depression and the targeting of these therapies to better suit each individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted, non-invasive technique that utilizes currents to induce electrical fields that excite specific brain regions. The current recommended practice of rTMS involves the administration of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove more effective for the treatment of depression. The present study aims to determine the effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients through electrophysiological recordings of the brain taken before and after 6 weeks of stimulation. Additionally, the study aims to investigate various biological markers linked to clinical rTMS response; these brain markers will help in personalizing treatment for individuals suffering from MDD.
In a 3 years longitudinal, observational, multicentre study, about 500 women will be recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after delivery. The primary aim of the present study is to systematically explore and characterize risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of potential markers during the perinatal period (Life-ON study). Secondary aims are to explore the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3). The characterization of specific predictive and risk factors for PND may substantially contribute to improve preventive medical and social strategies for the affected women. The study results are expected to promote a better understanding of the relationship between sleep disorders and the development of PND and to confirm, in a large sample of women, the safety and efficacy of BLT both in prevention and treatment of PND.
The project aimed at identifying neuropsychobiological signatures of pharmacological sex-steroid hormone manipulations in healthy women as a risk model for depression. The study is a double-blind, randomized, placebo-controlled study. Investigators included 63 healthy female volunteers with regular menstrual cycles between 23 and 35 days. Participants were randomized to active Gonadotrophin-Releasing-Hormone agonist (GnRHa) (goserelin 3.6 mg implant) or placebo (saline injection) intervention, which was initiated in the mid follicular phase (i.e. cycle day 22.6 ±2.5). Sixty women completed follow-up and entered the analyses, except for a few drop outs on some domains. The following domains were addressed at baseline and at follow-up (16±3 days post intervention), (which corresponded to the early ovarian suppression phase of the biphasic hormone response to GnRHa): 1) serotonin transporter binding as imaged by 11CDASB Positron Emission Tomography (PET), 2) functional Magnetic Resonance Imaging (fMRI) emotional processing, 3) fMRI reward processing, 3) rating state fMRI (rsfMRI), 4) structural MRI, 5) Neuropsychology, 6) Psychophysiology, 7) Hypothalamus-Pituitary-Adrenal cortex (HPA)-axis dynamics, 8) Peripheral markers of immunoactive cell responses, 9) Epigenetic factors. Psychometrics in terms of self reported mental distress and interview based ratings were monitored across the intervention period to monitor potential symptoms of mental distress and psychopathology. Also ovarian hormone responses, peripheral blood markers, and side effects scores were collected across the intervention period.
Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).
Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental illnesses" and it is also a highly recurrent disorder. Secondary prevention has been identified as a key goal in the long-term management of depression. High recurrence rate suggests that there are specific vulnerability factors that increase people's risk for developing repeated episodes of the disorder. Preventive strategies should identify and ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased attention for emotional stimuli is central to the cognitive model where increased sensitivity to negative cues is believed to fuel the negative thoughts and feelings in depression and play a key role in maintaining the illness. Selective biases in attention can be modified by a simple computerized technique; The Attention Bias Modification Task (ABM). This project aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a large group highly vulnerable to depressive episodes. The effects of ABM, immediately after the two weeks intervention, on three key risk factors for depression will be studied: Residual symptoms, cortisol awakening response and emotion regulation strategies. The participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that ABM will reduce subsequent episodes of low mood over the following 12 months in this group in a manner predicted by early changes in these risk factors will be investigated. It will also be tested if such effects in the lab may be dependent on candidate genes which affect serotonin reuptake and which have been implicated in malleability and emotional learning. Effects on underlying neural correlates of emotion regulation will be studied in an fMRI experiment in a sub-sample and which will also be stratified by serotonin transporter genotype (see also NCT02931487). The predictive value of meta cognitions related to rumination and the possible mediating effects of automatic thoughts and perceived stress will also be investigated in a sub group (see also NCT02648165). The characterization of the cognitive, genetic and neural mechanisms underlying the ABM effect will have key implications for future treatment development and combination with other treatment modalities like pharmacotherapy.
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment