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NCT ID: NCT02738944 Completed - Bipolar Disorder Clinical Trials

Study to Promote Innovation in Rural Integrated Telepsychiatry

SPIRIT
Start date: November 2016
Phase: N/A
Study type: Interventional

Background: Community Health Centers care for over 20 million rural, low income and minority Americans every year. Patients often have complex mental health problems such as Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers located in rural areas face substantial challenges to managing these patients due to lack of onsite mental health specialists, stigma and poor geographic access to specialty mental health services in the community. As a consequence, many rural primary care providers feel obligated, yet unprepared, to manage these disorders, and many patients receive inadequate treatment and continue to struggle with their symptoms. While integrated care models and telepsychiatry referral models are both promising approaches to managing patients with complex mental health problems in rural primary care settings, there have been no studies comparing which approach is more effective for which types of patients. Objectives: The central question examined by this study is whether it is better for offsite mental health specialists to support primary care providers' treatment of patients with PTSD and Bipolar Disorder through an integrated care model or to use telemedicine technology to facilitate referrals to offsite mental health specialists. We hypothesize that patients randomized to integrated care will have better outcomes than patients randomized to referral care. Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited from Community Health Centers in three states (Arkansas, Michigan and Washington) and randomized to the integrated care model or the referral model. Patient Outcomes: Telephone surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups. Telephone surveys will measure access to care, therapeutic alliance with providers, patient-centeredness, patient activation, satisfaction with care, appointment attendance, medication adherence, self-reported clinical symptoms, medication side-effects, health related quality of life, and progress towards life goals. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, primary care providers will be invited to participate in qualitative interviews to voice their perspective.

NCT ID: NCT02738281 Completed - Rett Syndrome Clinical Trials

Natural History of Rett Syndrome & Related Disorders

Start date: November 2015
Phase:
Study type: Observational

The purpose of this study is to advance understanding of the natural history of Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT including the range of clinical involvement and to correlate genotype-phenotype over a broad spectrum of phenotypes. While much has been learned about RTT, improvements are required in understanding the role of factors such as X chromosome inactivation, genetic background, and others including the environment, on the great variability observed even between individuals with the same MECP2 mutation. These data will be essential to the development and conduct of clinical trials that are anticipated from ongoing studies in animal models for RTT. This study will not include clinical trials, but should set the stage for such trials and other translational research projects (e.g., development of biomarkers).

NCT ID: NCT02737033 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder

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

This study evaluates the use of Rhodiola rosea in the attention of adults with Attention Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea 800mg, while the other half will receive 800mg of placebo.

NCT ID: NCT02737020 Recruiting - Clinical trials for Attention Deficit/Hyperactivity Disorder

Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

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

This study evaluates the use of Rhodiola rosea in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola rosea, while the other half will receive placebo.

NCT ID: NCT02734693 Completed - Clinical trials for Attention-Deficit Hyperactivity Disorder (ADHD)

A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

Start date: April 30, 2016
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of dasotraline in children 6 years of age to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

NCT ID: NCT02733120 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder

ASD
Start date: October 2015
Phase: N/A
Study type: Interventional

The objective of this study is to gain preliminary information and knowledge on metabolic profile in ASD. The benefit of this study will be to expand our insight of the potential relationship in metabolic processes and neuropsychological functions in ASD. For example, based on the obtained data of the study we can determine whether there is a link between the tryptophan pathway and cognitive functions in autism. The project is based on a systematic and multidisciplinary approach using tracers for delineating the mechanism by which the metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD. Using an innovative approach to the evaluation of amino acids has not been used in adults with ASD. In addition, the obtained data of the study holds promise to develop specific markers (metabolic and/or neuropsychological) for guiding the identification those individuals with increased risk of developing mood disturbances or cognitive impairment, and for predicting the therapeutic effect of a specific nutritional interventions in subjects with ASD.

NCT ID: NCT02724735 Recruiting - Clinical trials for Major Depressive Disorder

A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder

Start date: August 2016
Phase: N/A
Study type: Observational

All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.

NCT ID: NCT02723097 Completed - Clinical trials for Post Traumatic Stress Disorder (PTSD)

A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.

NCT ID: NCT02722967 Completed - Schizophrenia Clinical Trials

Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

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

This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

NCT ID: NCT02720731 Recruiting - Pain Clinical Trials

Care-related Pain and Discomfort in People With Motor Disorder

DIS-HANDI
Start date: April 2016
Phase: N/A
Study type: Observational

The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up. All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS). Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.