View clinical trials related to Depressive Disorder, Major.
Filter by:Currently, very little research exists on whether patient portals could be used to integrate patient-reported outcome (PRO) measurement into the electronic health record (EHR) and clinical practice, even though 87% of ambulatory care practices have EHRs and 88% of U.S. adults have access to the internet. To date, no randomized controlled trial has examined whether patient portals can be used to collect PRO measures. The goal of this study is to implement the integration of a computerized adaptive test (CAT) for patient-reported outcome (PRO) measurement of depression symptoms into an electronic health record (EHR) and evaluate the effectiveness of collecting CAT PROs via an EHR patient portal in two randomized controlled trials. This study will advance the science of implementation of patient-centered outcomes research into clinical practice, as well as the evidence for high quality, accessible care.
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.
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.
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.
The objective of this study is to evaluate the feasibility of adding a navigational system to traditional repetitive Transcranial Magnetic Stimulation (rTMS, referred to in this application as nTMS) as a way to establish and maintain precise coil positioning (contact, rotation, and tilt) and consistent brain region targeting throughout a nTMS treatment session and in subsequent nTMS sessions.
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.
Research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. Healthy people, however, change their expectations after unexpected positive experiences. In this experimental study, it will now be examined whether there are also differences between healthy people and people with depressive symptoms in dealing with unexpected negative experiences.
Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. SSRIs are commonly prescribed in elderly depressed patients and, although generally safe, they may be associated with tolerability issues. Based on available studies, vortioxetine is likely to have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, wakefulness, body weight, and electrocardiogram parameters. Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine compared with the SSRIs as a group (including sertraline, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The primary outcome will be the withdrawal rate due to adverse events. Methods. This is a pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial. Twelve Italian Community Psychiatric Services will consecutively enrol elderly patients suffering from an episode of major depression who get in contact over a period of 12 months. By employing the web-based application RedCap, doctors will be able to randomize patients to vortioxetine or one of the SSRIs, chosen on the basis of clinical judgment, and to collect basic socio-demographic and clinical data. Trained and blinded assessors will administer five validated rating scales: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Charlson Age-Comorbidity Index (CACI), and Short Blessed Test (SBT). Patients will be assessed after 1, 3 and 6 months. Expected results. On the basis of current literature, the investigators hypothesize vortioxetine to be superior to SSRIs as a group in terms of tolerability. As vortioxetine is expected to reduce the withdrawal rates due to adverse events of about 12% compared to SSRIs, and assuming that about 23% of the participants could be lost within 6 months, the investigators aim to enrol 358 patients (179 in each group).