View clinical trials related to Major Depressive Disorder.
Filter by:The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.
Background: despite developments a substantial part of patients with depression will only recover slowly. Light therapy from light boxes has shown antidepressant effects but have several limitations: time consuming, only allowing a fixed spectral distribution, only delivered at a specific time-point, and often with inadequate light intensity delivered at the retina. Therefore, we developed a new dynamic lighting system using light fixtures that are built into the room and can change intensity and spectral distribution of light during the 24-hour day. Objectives: the objective of this trial is to assess the beneficial and harmful effects of a newly developed dynamic lighting system using Light Emitting Diodes (LED) -light armatures aiming to mimic sunlight, when installed in the patient rooms of a psychiatric inpatient ward, compared with usual care. Design: the design is a randomised controlled trial with two arms: an active dynamic light trial arm and a usual care arm with blinding of depression outcome, and data analyses. Randomisation will be 1:1. Inclusion criteria: a current episode of a major depressive episode as part of a unipolar or bipolar disorder. Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilising treatment, age > 18 years, informed consent. Exclusion criteria: severe suicidality, abuse of alcohol and / or drugs, actual psychotic state, Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode. Interventions: the experimental intervention is a dynamic LED-light system in 10 separate patient single rooms with three dynamic lamps: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. The usual care is constant standard LED-light. Primary outcome: score on the Hamilton Depression Rating Scale 6 item version (HAM-D6) scale at week 3 Secondary outcomes: score on the Suicidal Ideation Attribution Scale (SIDAS ) scale at week 3, and score in the Hamilton. Depression Rating Scale 17 item version (HAM-D17) scale at week 3, and score on the World Health Organisation Quality Of Life questionaire abbreviated version (WHOQOL-BREF) at week 3. Trial size: in total, 150 patients. Time schedule: the trial will be submitted for regulatory approvals January 2019, the first participant will be included April 2019, the expected last follow-up of the last participant will be December 2020, the expected last follow-up after 6 months will be June 2021, data will be analysed from June 2021 till September 2021, manuscripts will be prepared from December 2020, and we expect to submit first manuscript December 2021.
The goal of this study is to develop new methods of administering antidepressant medications that will result in improved drug/placebo separation in randomized controlled trials (RCTs) for Major Depressive Disorder (MDD) and enhanced medication response in open clinical treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs radically differs from how antidepressant medications are prescribed in standard clinical practice and is believed to be a major reason why the majority of studies submitted to the Food and Drug Administration (FDA) fail to show a significant difference between medication and placebo. Moreover, a "one size fits all" approach to psychopharmacologic management (i.e., weekly visits for all patients) does not take into account differences between patients that may predispose some individuals to respond positively to frequent follow-up visits, while others may respond negatively or not at all. Clinic visits comprise multiple components that may be therapeutic for depression, including activating patients' behavior, exposing them to medical procedures, permitting social interactions with research staff, and providing supportive meetings with clinicians. Two independent meta-analyses have associated more frequent study visits with increased antidepressant and placebo response as well as decreased separation between medication and placebo. Despite the high costs and potential disadvantages of weekly follow-up visits for patients receiving antidepressant medication, this clinical management strategy has not been studied prospectively to date. It is unknown whether weekly follow-up visits are needed to ensure treatment compliance and patient safety in clinical trials and to what degree contacts with clinicians influence medication and placebo response.
Lithium is a mainstay in the treatment of bipolar disorder, and a frequently used adjunctive therapy for major depressive disorder. It is accepted practice to monitor lithium serum levels to monitor for efficacy and toxicity. However, studies on the difference in lithium levels between once and twice daily dosing, which also assess the impact of kidney function are scarce. The aim of this study is to quantify this pharmacokinetic difference, identify the impact of kidney function, in the context of estimating effects to inform feasibility and sample size needed for a larger well-powered study.
This study aims to examine whether multiple spaced sessions of intermittent theta-burst transcranial magnetic stimulation (iTBS) induce anti-depressant responses and reduce opiate cravings in adults with opiate use disorder (OUD). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.
Hormonal transitions such as across pregnancy and postpartum may trigger depressive episodes in some women. It is not known why, but estrogen sensitivity may play a critical role. A preclinical human risk model showed that depressive symptoms induced by pharmacological sex-hormone manipulation is linked to increases in serotonin transporter (SERT) brain binding, which lowers serotonergic brain tone. It is currently unknown if these findings translates to women across pre- to postpartum transitions. This longitudinal project studies a group of women who will deliver by planned caesarian, thus permitting the collection of cerebrospinal fluid (csf) containing central markers of serotonergic signaling, at the latest point in pregnancy. The women are followed across late pregnancy, delivery and 6 months postpartum to illuminate relations between sex-hormones, stress-regulation, estradiol sensitivity, csf markers of neurotransmission, serotonin transporter genotype variance, and potential development of subclinical or manifest depressive symptoms. Further, markers of relevance for the infant brain development and stress-regulation will be obtained from placenta tissue and umbilical cord blood. A subgroup of 70 women will participate in a brain imaging program early postpartum (week 3-5), which includes an evaluation of brain activity and structure and in vivo molecular brain imaging serotonergic markers. Thus, serotonergic markers in csf can be combined with postpartum molecular brain imaging of key features of serotonin signaling. Women in the imaging program are selected based on variation in their level of mental distress immediately postpartum (day 2-5). The study's main hypothesis is that women with high-expressing SERT genotypes are more sensitive to peripartum hormonal transition in terms of changes in serotonergic tone and emergence of depressive symptoms and that such an association will be stronger in the presence of candidate gene transcript biomarkers of oestrogen sensitivity. A further hypothesis is that in vivo molecular brain imaging and csf based serotonergic markers will be associated with depressive symptoms both early and later postpartum. Ideally, this project will provide a rationale for future targeted prevention and/or treatment of perinatal depression in women at high risk, which holds grand potential to protect not only mother but also infant brain health long-term.
This study aims to screen and validate multi-scale bio-markers for early diagnosis and medication monitoring for early schizophrenia, including the genetic, neurobiochemistry, neuroimaging and eletrophysiological measures. Based on the validated bio-markers, the present study further tries to build several prediction models for early differential diagnosis of schizophrenia from healthy controls and other mental diseases (such as the major depression and anxiety disorders), biological sub-typing and diagnosis of the schizophrenia sub-types, and early prediction of the medication effects.
Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.
This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a range of psychological disorders, especially MDD. MDD is a major public health concern and a leading cause of disability worldwide. A shift in treatment perspectives, from a disorder-specific approach to a transdiagnostic approach, has been proposed. While the disorder-specific approach tends to understand and treat different mental disorders as independent psychological problems, the transdiagnostic approach aims to identify common clinical features (e.g. sleep disturbances) across a range of psychological disorders. The transdiagnostic approach would potentially facilitate timely dissemination of evidence-based psychological treatments and contribute to significant public health implications. This study will be a randomized controlled trial on the efficacy of TranS-C for MDD. TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 150 eligible participants will be randomly assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in the TranS-C group will receive TranS-C once per week for 6 consecutive weeks respectively. The group treatment will be delivered by a clinical psychology trainee under the supervision of a clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil questionnaires before the treatment commences, 1-week, and 12-week after the treatment sessions are completed. The CAU group will complete the same set of online/paper-and-pencil questionnaires during the same periods.
This study was a multicenter, randomized, double-blind, placebo, parallel-controlled, dose-finding Phase II clinical trial to find the optimal dose of LY03005 Extended-release Tablets for the treatment of MDD and to evaluate the preliminary efficacy and safety, providing a basis for the design of phase III clinical trials and the determination of dosing regimens.