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NCT ID: NCT01331304 Completed - Bipolar Disorder Clinical Trials

Comparative Effectiveness Study for Bipolar Disorder

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effectiveness of lithium and quetiapine for the treatment of individuals with bipolar disorder.

NCT ID: NCT01330485 Completed - Clinical trials for Major Depressive Disorder

Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Start date: November 2010
Phase: N/A
Study type: Interventional

The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).

NCT ID: NCT01329133 Completed - Clinical trials for Obsessive-Compulsive Disorder

Deep Brain Stimulation and Obsessive-compulsive Disorder

STOC2
Start date: April 4, 2011
Phase: Phase 3
Study type: Interventional

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

NCT ID: NCT01327924 Completed - Clinical trials for Chronic Kidney Disease

Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

Start date: April 2011
Phase: N/A
Study type: Observational

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

NCT ID: NCT01327040 Completed - Clinical trials for Sleep Disorders, Circadian Rhythm

Light Sensitization Study

Start date: October 2010
Phase: N/A
Study type: Interventional

Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical use. In this study the investigators will test whether pre-exposure to dim light may enhance the response of the circadian system to light therapy. If so, this could result in shorter treatments that would have greater practical applications.

NCT ID: NCT01324973 Completed - Obesity Clinical Trials

Web-Based Weight Management for Individuals With Mental Illness

eWellness
Start date: March 2012
Phase: N/A
Study type: Interventional

Obesity and physical inactivity have become serious problems for individuals with mental illness, resulting in increased rates of chronic disease, premature death, and substantial health care costs. Although in-person psychoeducational interventions help individuals with mental illness manage their weight, these interventions are often not used because they require frequent travel to treatment programs and substantial time from clinicians. This project addresses these barriers by developing and evaluating the effectiveness of an web-based computer system that is focused on diet and exercise education, and designed to help individuals with mental illness manage their weight.

NCT ID: NCT01323478 Completed - Clinical trials for Major Depressive Disorder

Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

Start date: April 2011
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

NCT ID: NCT01322269 Completed - Sickle Cell Disease Clinical Trials

A Study of HQK-1001 in Patients With Sickle Cell Disease

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of three dose levels of HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.

NCT ID: NCT01321177 Completed - Schizophrenia Clinical Trials

An Integrated Program for the Treatment of First Episode of Psychosis

RAISE ETP
Start date: July 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.

NCT ID: NCT01316796 Completed - Sickle Cell Disease Clinical Trials

Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders

Start date: March 15, 2011
Phase: Phase 1
Study type: Interventional

Background: - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease, thalassemia, and other red blood cell disorders. In these disorders, red blood cells break down earlier than normal, which researchers suspect may cause or contribute to the development of leg ulcers; however, the exact cause is unknown, and current therapies are not very effective. Researchers are interested in determining if a research cream made with sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels, may speed up the healing of skin ulcers. Objectives: - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders. Eligibility: - Individuals at least 18 years of age who have sickle cell disease or another red cell disorder and have had a leg ulcer for more than 4 weeks. Design: - Participants will be screened with a physical examination, medical history, blood tests, and an examination of the ulcer, including x-ray of the leg(s) with the ulcer and swabs from the wound. - Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with the following procedures: - Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the affected leg, imaging studies (magnetic resonance imaging and infrared photography), thermo-patch application to monitor temperature changes, measurements of blood flow in the skin, and questionnaires about pain and quality of life. An optional skin biopsy may also be conducted with samples taken near the skin ulcer - Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood draws will be conducted before application and then regularly for up to 6 hours after application of the cream. Thirty minutes after the research cream is applied, participants will have imaging studies of the treated leg and measurements of pain levels and blood flow. - Day 4: Participants will have a blood draw and temperature recordings taken. - Day 5: Participants will have the research cream applied and the same imaging studies as before, and will be discharged for care at home. - For the following 3 weeks, participants will come to the clinical center twice a week to have the research cream applied to the leg ulcer and tests performed by the study researchers. - For the fourth and final week, participants will return for additional cream treatment sessions, imaging studies, blood draws, and other tests as directed by the study researchers. - Study participation will end in the following week (week 5). Subjects will come for a final visit one month after the end of the study.