Clinical Trials Logo

Depressive Disorder clinical trials

View clinical trials related to Depressive Disorder.

Filter by:

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: NCT02218138 Completed - Obesity Clinical Trials

Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls

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

Type 2 diabetes is a chronic disease that puts people at risk for major health problems like heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor insulin sensitivity, meaning that insulin - an important chemical the body makes to keep blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed have worse insulin sensitivity than individuals who do not feel stressed. In adults, decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested in teenagers. The purpose of this study is to find out if taking part in a brief group program to decrease stress will improve insulin sensitivity and lower diabetes risk in teenage girls.

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: NCT02214511 Completed - Clinical trials for Major Depressive Disorder

Biomarkers of Social Sensitivity in Major Depression

SENSO
Start date: October 23, 2014
Phase:
Study type: Observational

Major depression disorder (MDD) is a frequent and disabling mental disorder with great risk of recurrence and chronicity. Interpersonal factors are among the strongest predictors of the course and duration of an episode of depression. More specifically, social rejection is one of the most environmental risk factors of MDD. Targeted rejection predicts hastened onset of major depression. On the other hand, healthy subject show prosocial behavior after social rejection to reconnect to new source of social interaction. In addition to the potential impact of social exclusion on MDD onset, depressed patients may be more prone to be rejected as they encounter interpersonal difficulties and may less be able to reconnect to the social group after rejection. Recent neuroimaging data show that brain processing of social exclusion activate brain regions that are central to the pathophysiology of MDD. Some of these regions are also known to be activated during physical pain and may contribute to the aversive dimension of the experienced rejection. Pro-inflammatory cytokines are involved in MDD physiopathology and can induce social withdrawal behavior. Inflammation can modulate social interactions in mammals. Moreover, after a social stress such as social rejection, blood cytokines increase. At a cognitive level, self-esteem can modulate the sensitivity to social rejection. The major objective of the trial is to study sensitivity to social signals in MDD patient compared to healthy subject. The investigators hypothesize in MDD patient : (1) decrease of rapid facial reactions (RFR) to dynamic emotional faces expressing joy, (2) increase of RFR to dynamic emotional faces expressing sadness, (3) decrease of prosocial reaction after experimental social rejection. Secondary objective is to identify psychological and biological mediators We hypothetize in MDD patient: (1)mediating effect of systemic inflammatory cytokines, an (2) mediating effect of state self esteem 30 MDD patients and 60 healthy subject will be included. They will encounter psychiatric and psychometric evaluation. Their facial EMG will be recorded to assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces database, coupled to occulometric recording. Subjects will perform cyberball game as an experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of their prosocial behavior. Questionnaires will assess explicit measurement of social rejection pain and desire of affiliation. Inflammatory markers will be measured in a blood sample before the cyberball task for every subjects and 6 hours later for 20 healthy volunteers. Dosage of IL-6, IL-10, TNFa, IP-10, MCP-1, MIP-1b, Rantes, sIL-6Ra, IL1ra, VEGF, Leptin, PECAM1, sTie2, sVEGFR1, sVEGFR2 will be performed by luminex technique and usCRP, srIL2 ans sCD14 by ELISA technique.

NCT ID: NCT02213601 Completed - Clinical trials for Depression, Postpartum

Efficacy of Yoga for Postpartum Depression

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

The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative to a wait-list control (WLC) condition, for improving psychological functioning and health-related quality of life in depressed postpartum women. It was hypothesized that the yoga intervention would be significantly more efficacious than the wait-list control condition in reducing symptoms of depression and anxiety, and improving health-related quality of life, at the end of the 8-week yoga intervention.

NCT ID: NCT02212366 Completed - Depression Clinical Trials

To Enhance Cognition in Late Life Depression Using Transcranial Direct Current Stimulation

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

Late Life Depression (LLD) is a serious health problem which not only causes depressed mood but also results in impairments in memory and attention. These impairments are likely to be resistant to treatment, which increases the chances of developing dementia even after successful treatment of mood.This study is a randomized controlled trial of transcranial Direct Current Stimulation (tDCS) in people with LLD to enhance their cognition after successful treatment of mood with established medications. tDCS is non invasive, relatively inexpensive and portable, and has been found to be safe.This study also serves as a pilot study to assess the effects of tDCS on cognition and neurophysiologic markers of cognition among patients with LLD. Primary study hypothesis is that participants Participants randomized to tDCS will perform better on a working memory task 2 weeks and 3 months following the tDCS course.

NCT ID: NCT02209597 Completed - Clinical trials for Major Depressive Disorder

Clinical Study of Generic and Brand Bupropion in Depression

BALANCE
Start date: June 25, 2014
Phase: Phase 4
Study type: Interventional

Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

NCT ID: NCT02209142 Completed - Clinical trials for Major Depressive Disorder

Blood Biomarkers in Major Depression

Start date: February 22, 2012
Phase: N/A
Study type: Interventional

Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.

NCT ID: NCT02200406 Completed - Depression Clinical Trials

Desvenlafaxine in Opioid-Dependent Patients

Start date: July 2014
Phase: Phase 4
Study type: Interventional

Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.

NCT ID: NCT02200367 Completed - Depression Clinical Trials

E-mental Health Support for Rural Areas

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

In the treatment of depression, primary care team play an important role, but they are most effective when inserted into a collaborative model of disease management. Hypotheses:Depressed patients treated in rural primary care clinics participating in a e-mental heath collaborative programme to manage depression achieve at least 20% better recovery rates in comparison with the control group three months after the baseline assessment. Goal: to compare the effectiveness of a e-mental health collaborative programme with usual care in rural primary-care clinics. Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals in Chile. The active group will participate in a collaborative programme between primary care teams and specialized teams, with support from an electronic platform and a call center.The control group will receive usual care, according to the Ministry of Health's Guidelines to Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years- and exclusion criteria -current in treatment for depression- an interview will be used that will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression .The principal outcome will be depressive symptoms measured with the Beck Depression Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the design effect the sample needed increased to 206 depressed persons. Considering a retention rate of approximately 85% 237 depressed cases will be needed. A program of this kind may be useful to assist primary care teams in remote areas of the country, in order to improve treatment outcomes for depression that is currently addressed at the primary care level.