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NCT ID: NCT02225106 Completed - Clinical trials for Traumatic Brain Injury

Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI

DAPET-TBI
Start date: August 6, 2014
Phase: Phase 2
Study type: Interventional

Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine transporters (DAT) and blocking re-uptake. The objectives of this study are to use PET imaging with [11C]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to measure endogenous DA release in patients who are experiencing problems with cognition, attention and executive function in the chronic stage after TBI. In addition, we will use TMS to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) - mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity on and off

NCT ID: NCT02225041 Completed - Clinical trials for Intellectual Disability

Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

RESTORE-cog
Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to determine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and dose-dependent relationships between sedative exposure and neurocognitive outcomes along the early developmental spectrum and will control for baseline and environmental factors, as well as the severity and course of illness. Hypotheses: 1. Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ even when controlling for severity of illness, hospital course, and baseline factors. In addition, benzodiazepines and/or ketamine will negatively affect other aspects of neurocognitive function. 2. Younger children exposed to benzodiazepines and/or ketamine will have worse neurocognitive outcomes than older children with similar sedative exposure and severity of illness.

NCT ID: NCT02224508 Completed - Pain Clinical Trials

Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks

CARE
Start date: September 2014
Phase: N/A
Study type: Observational

Background: Sixty million American adults suffer from moderate to severe chronic pain. Of these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a large nonprofit health plan, developed and implemented opioid risk reduction strategies for doctors and patients in some, but not all, of its clinics. The risk reduction initiative achieved large opioid dose reductions, near universal documentation of care plans, and marked increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the opioid risk reduction initiative, incorporating patient perspectives, is needed to guide health care improvement efforts to reduce opioid risks regionally and nationally. Research goal: The investigators will evaluate a major health plan initiative to reduce risks of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced prescribing of high opioid doses. In 2010 the same clinics increased care planning and monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects of this initiative on health and safety outcomes of COT patients. We will test whether the initiative influenced pain outcomes; patient-reported opioid benefits and problems; and opioid-related adverse events. Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction initiative among COT patients using opioids long-term. The investigators will compare COT patients from clinics that implemented the initiative with COT patients from care settings that did not implement the initiative. The investigators will use survey data to assess patient-reported outcomes including pain severity, depressive symptoms, and patient perceptions of opioid benefits and problems, including validated measures of prescription opioid use disorder. They will interview and compare 800 COT patients using opioids long-term from clinics that implemented the risk reduction initiative and 800 COT patients from care settings that did not. Impact: This research will provide an urgently needed, rigorous evaluation of a major risk reduction initiative among COT patients. Evaluation results will guide efforts of health plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic pain care.

NCT ID: NCT02222285 Completed - Autistic Disorder Clinical Trials

An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)

Start date: August 2014
Phase: N/A
Study type: Interventional

The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.

NCT ID: NCT02221336 Completed - Bipolar Disorder Clinical Trials

Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial

MONARCAII
Start date: September 2014
Phase: N/A
Study type: Interventional

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment. Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms. In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.

NCT ID: NCT02219880 Completed - Clinical trials for Generalized Anxiety Disorder

Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

KGAD
Start date: October 13, 2015
Phase: Phase 4
Study type: Interventional

The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.

NCT ID: NCT02218853 Completed - Clinical trials for Bipolar I Disorder, Unspecified, Without Psychotic Features

Psychosis and Affective Research Domains and Intermediate Phenotypes

PARDIP
Start date: April 2014
Phase:
Study type: Observational

The objective of this multi-site research collaboration is to test the manifestation and distribution of biological markers for psychosis and affect dimensions across the schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic associations for these biological markers.

NCT ID: NCT02218736 Completed - Clinical trials for ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)

Fast-Fail Trials in Mood and Anxiety Spectrum Disorders; Kappa Opioid Receptor Phase 2a

FASTMAS_Kor2
Start date: June 2015
Phase: Phase 2
Study type: Interventional

The available treatment for patients with mood and anxiety disorders have significant limitations (Rush, 2007; Denys and de Geus, 2005). There is a need to develop new treatments for people with these disorders. Many research studies carried out in animals and a few preliminary studies carried out in humans suggest that medications which block kappa opioid receptors (KOR) have potential for being effective new treatments for patients with mood and anxiety spectrum disorders. These medications have shown particular promise for improving one important type of difficulty experienced by many patients who suffer from mood and anxiety spectrum disorders referred to as anhedonia, which is an impairment in reward-related function. In this study we will test the hypothesis that KOR antagonism is a promising means of improving anhedonia in patients with mood and anxiety spectrum disorders. We will do so by evaluating whether we can establish Proof of Concept (POC) that a relatively selective KOR antagonist, CERC-501 (formerly known as LY2456302), engages neural circuits involved in mediating reward-related function in patients with mood and anxiety spectrum disorders with anhedonia. We are attempting to establish POC in this study in order to determine whether there is a sufficient basis for pursuing future work evaluating whether KOR antagonism has therapeutic effects on clinical and behavioral measures of reward-related functioning.

NCT ID: NCT02218008 Completed - Clinical trials for Major Depressive Disorder

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of ALKS 5461.

NCT ID: NCT02217371 Completed - Clinical trials for Attention-Deficit/Hyperactivity Disorder

Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity

VEILLETDAH
Start date: September 2, 2014
Phase: N/A
Study type: Interventional

In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus, we wish to determine potential changes in the regulation of sleep / wake cycle through a protocol of extended wake. The principal objective is to compare the objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake. It's an observational study of interventional type realized in patient with ADHD syndrome deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the implication of the homeostatic and circadian systems in the preservation of awakening.