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NCT ID: NCT01908062 Completed - Clinical trials for Alcohol Use Disorder

Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

CHOICES
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.

NCT ID: NCT01906268 Recruiting - Clinical trials for Generalized Anxiety Disorder

Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Start date: July 2013
Phase: N/A
Study type: Interventional

The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.

NCT ID: NCT01905839 Terminated - Parkinson's Disease Clinical Trials

A Study of Movement Disorders Using the QMAT At-Home Testing Device

Start date: June 18, 2013
Phase:
Study type: Observational

Background: - Parkinson s disease (PD) affects half a million Americans, causing slow movements, tremors, stiffness, and trouble walking. Currently, these symptoms are measured by physical exam, but this is unreliable and requires an office visit. Researchers want to study a different way to measure PD symptoms, using a home-testing machine called a QMAT device. It can test how quickly someone moves doing different tasks. Researchers will study how this testing compares to physical exam testing and whether the device can detect changes in PD symptoms over time. Objectives: - To see if a home testing device can be used to evaluate Parkinson s disease symptoms. Eligibility: - Adults at least 18 years old with PD. Design: - Participants will have about 22 clinic visits over 5 years. Each visit will take up to 3 hours. Visits will be scheduled along with visits for another study. - At visit 1, participants will learn to use the QMAT device and how to send testing information to the clinic by computer. The device has a computer screen, some buttons, and some pegs. Participants will get a device to take home and any accessories. - Participants will learn 2 QMAT tests. For one, they will press keys as fast as possible. For the other, they will move pegs into holes. The tests will take a total of about 20 minutes. - Participants will take both tests at home, 2 times on the same day each week, once before their medication, once after. - A study coordinator will monitor the participant s computer data and discuss the at-home testing at the clinic visits.

NCT ID: NCT01903200 Completed - Clinical trials for Major Depressive Disorder Patients

Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder

Start date: February 2010
Phase: Phase 1
Study type: Interventional

The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD).

NCT ID: NCT01903096 Completed - Anxiety Disorders Clinical Trials

Treating Emotional Disorders in Primary Care With Psychological Techniques

PsychPC
Start date: January 14, 2014
Phase: Phase 4
Study type: Interventional

The strong demand for primary care (PC) services in Spain exceeds resources. Part of this demand is due to the increasing number of anxiety, depression, and somatization disorders that affect the general population. These disorders, commonly known as emotional disorders, are very common in Spanish PC settings, they are poorly detected by physicians, rarely receive adequate treatment (if they receive treatment it is mostly drugs instead of psychological treatment), they generate a highly frequent use of PC services, a greater burden than physical diseases and tend to become chronic without treatment. Other countries have successfully put psychological techniques in PC into practice (in the United Kingdom the program known as "Improving Access to Psychological Therapies" has obtained very positive results) in order to correctly diagnose and treat emotional disorders. The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better than the usual treatment offered in PC services, involving no side effects, fewer relapses, and lower costs in the long term. The general aim of this study is to test how well a psychological treatment program for anxiety, depression, and somatization disorders works in PC and to compare the results obtained after seven 90-minute group sessions (every to two to four weeks approximately, for a period of 24 weeks) with the usual treatment offered in Spanish PC services. Similar results to the ones already obtained in other countries are expected to be found. Approximately 1130 adults, regardless of their age and sex, with an anxiety, depression and/or somatization disorder (diagnosed with a simple and short questionnaire) will participate in this study. Participation will be voluntary and confidentiality will be guaranteed. Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment, within the same health care centre. Since it is a "double-blind" study, neither the health professional nor the patient will know which treatment will be applied. Psychological assessments will be carried out before and after receiving treatment and participants will be followed up at 3, 6 and 12 months. Participation will pose no risks different from the typically present when receiving usual treatment. The aim of this study will be to maximize benefits and reduce potential harms (principle of proportionality).

NCT ID: NCT01902641 Completed - Clinical trials for Patient Satisfaction

Muscle Relaxation for Short Procedures

Start date: October 2011
Phase: N/A
Study type: Interventional

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants.

NCT ID: NCT01901380 Completed - Clinical trials for Functional Gastrointestinal Disorders

Cow's Milk Allergy and Functional Gastrointestinal Disorders

Start date: February 2013
Phase: N/A
Study type: Observational

Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. Intestinal microflora has been indicated as potential target for the management of CMA and FGDIs through the use of probiotics. Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of LGG, satisfying both the American Academy of Pediatrics guidelines. Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. Studies and meta-analyses showed that LGG increases treatment success in children with functional gastrointestinal disorders.

NCT ID: NCT01896388 Completed - Clinical trials for Posttraumatic Stress Disorders

Ifenprodil Tartrate Treatment of Adolescents With Post-traumatic Stress Disorder: a Double-blind, Placebo-controlled Trial

Start date: January 21, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Accumulating evidence suggests a key role of the N-methyl-D-aspartate (NMDA) receptor in the pathophysiology of post-traumatic stress disorder (PTSD). Recent studies suggest that the NMDA receptor antagonist ifenprodil tartrate may be a potential therapeutic drug for PTSD. The purpose of this study is to confirm whether ifenprodil tartrate is effective in the treatment of adolescents PTSD patients. If ifenprodil tartrate is effective in these patients, this study contributes to the development of novel therapeutic drugs for PTSD.

NCT ID: NCT01894815 Completed - Clinical trials for Major Depressive Disorder

Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial

ELECT-TDCS
Start date: October 2013
Phase: Phase 3
Study type: Interventional

Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness and adverse effects. In this context, the investigators investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is virtually absent of adverse effects. Its ease of use, portability and low price are also interesting characteristics for using in primary and secondary health care. Thus, our aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a noninferiority margin of at least 50% of the escitalopram-placebo effect.

NCT ID: NCT01892306 Completed - Bipolar Disorder Clinical Trials

Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder

Start date: June 2013
Phase: N/A
Study type: Interventional

The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.