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NCT ID: NCT02708186 Completed - Clinical trials for Dementia With Lewy Bodies

Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

Start date: March 2016
Phase: Phase 2
Study type: Interventional

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

NCT ID: NCT02708069 Completed - Autistic Disorder Clinical Trials

e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder

e-Unstuck
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The goal of this project is to develop and test e-Unstuck, an e-learning intervention that (1) provides advanced training to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) on how to implement the evidence-based Unstuck and On Target (UOT) curriculum at home and (2) is built on 3C's proprietary, state-of-the-art, Dynamic e-Learning Platform, an established platform with high ratings of quality, value, usability, and feasibility from end users. As a result of the pilot efficacy test, the investigators hypothesize that (1) parents who interact with the e-Unstuck software will report greater knowledge and use of UOT principles, less parenting stress and greater parenting sense of competence, and improved child executive function (EF) and social skills compared to control parents, (2) parents who spend more time engaged with the intervention will show greater improvements in outcome variables, and (3) parents who interact with the e-Unstuck software will find the software to be of high quality, value, usability, and feasibility.

NCT ID: NCT02707367 Completed - Mental Disorders Clinical Trials

Recovery Roadmap Phase II Small Business Innovation Research Grant

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a highly interactive web-based tool that provides guidance for providers and people in recovery, and promotes widespread implementation of Person-Centered Recovery Planning (PCRP). The Recovery Roadmap prototype was developed and tested by the Center for Social Innovation (C4), in partnership with Yale University's Program for Recovery and Community Health (PRCH), under a Phase I Small Business Innovative Research (SBIR) grant funded by the National Institute of Mental Health (NIMH) (1R43MH100712). Phase II refined the prototype Roadmap to streamline content, provide additional handouts and exercises for providers and clients to complete together, expand the audio/video vignettes and case studies, and add interactive online coaching and support for providers. Phase II also involved a robust evaluation of the Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 30 practitioners and 90 clients (two to three clients per practitioner) were recruited from a total of five Community Support Programs in Connecticut. The programs were randomly selected into one of two intervention waves (Wave 1 and Wave 2). Survey data for Wave 1 included a total of four surveys: a pre-observation period, post-observation/pre-intervention, a midpoint survey (after completion of online curriculum), and a post survey (after completion of the entire intervention, including coaching calls). Surveys for the Wave 2 study participants included a pre-intervention, midpoint, and post survey. Qualitative interviews were also completed with interviews with practitioners and and administrators/clinical supervisors in each agency. State level client administrative client data were also collected and analyzed. Data examined changes in knowledge related to PCRP, person centered planning practices, practitioner/client relationship, and overall feedback on the intervention. our team also conducted a social network analysis to examine any changes in the size and strength of their networks related to person centered planning before and after the intervention. This phase will culminate with the dissemination of findings and preparation for Phase III commercialization.

NCT ID: NCT02703363 Completed - Depression Clinical Trials

Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Start date: August 2016
Phase: Phase 3
Study type: Interventional

Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. In this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in patients experiencing a depressive phase of bipolar I or II disorder. The investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.

NCT ID: NCT02702466 Completed - Clinical trials for Musculoskeletal Disorders

Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).

MUSKA
Start date: September 2015
Phase: N/A
Study type: Interventional

The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives (personal or professional)

NCT ID: NCT02696434 Completed - Opioid Use Disorder Clinical Trials

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Start date: April 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.

NCT ID: NCT02696109 Completed - Depression Clinical Trials

Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial

Start date: February 2016
Phase: N/A
Study type: Interventional

The purpose of this study is exploring a theoretically guided intervention, Cornerstone, which provides system 'boundary-spanning' services, including therapeutic services and mentorship, to transition-age youth with mental disorders. Cornerstone is designed to improve mental health service engagement and outcomes. The study uses a mixed methods approach to refine Cornerstone, and a hybrid design examining feasibility, acceptability, and preliminary impact with a randomized trial, alongside implementation.

NCT ID: NCT02689765 Completed - Type 2 Diabetes Clinical Trials

Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Metabolic problems represent one of the major health concerns which are attractive for being addressed by nutritional interventions, as these are directly connected to dietary habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes alleviation properties, but association between anthocyans and prediabetes need to be more firmly understood and established from robust clinical data. However, there is little human research that has reported on the efficacy of increased anthocyans bioactive consumption on insulin sensitivity in pre-diabetes.

NCT ID: NCT02687555 Completed - Clinical trials for Post-Traumatic Stress Disorder

The Role of Computerized Training in Post-Traumatic Stress Disorder

Start date: February 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.

NCT ID: NCT02685982 Completed - Clinical trials for Major Depressive Disorder

Treating Major Depressive Disorder With Music and Low-frequency Rhythmic Sensory Stimulation

Start date: April 2016
Phase: N/A
Study type: Interventional

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.