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Depressive Disorder, Major clinical trials

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NCT ID: NCT02226042 Completed - Clinical trials for Major Depression (in Remission)

Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)

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

This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme. Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk. The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.

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: 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: NCT02196506 Completed - Depression Clinical Trials

Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

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

The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

NCT ID: NCT02191397 Completed - Clinical trials for Depressive Disorder, Major

Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder

Start date: February 10, 2015
Phase: Phase 3
Study type: Interventional

This multi-centre study will follow a randomised, double-blind, parallel-group, active-controlled design and will evaluate the efficacy, safety and tolerability of bupropion extended-release (XL) (300 mg/day) compared with escitalopram (10-20 mg/day) in outpatients and inpatients with major depressive disorder (MDD). The total duration of the study will be 11 weeks consisting of three phases. The screening phase (phase I) will be lasting for 0-14 days, subjects will be randomised to bupropion XL or escitalopram in a 1:1 ratio for acute phase treatment phase (phase II) for 8 weeks. There are 3 dose levels during this acute treatment phase. The 3-dose level plan is designed to ensure each drug is titrated according to the prescribing information and to reach an optimal clinical dose. Finally patients will enter the taper phase (phase III) for up to 1 week to assess and reduce the possible withdrawal symptoms. In China almost all existing antidepressants are available on the market, but bupropion XL has not yet been approved. This Phase III clinical trial will be used for the purpose of registering bupropion XL in China.

NCT ID: NCT02191384 Completed - Clinical trials for Major Depressive Disorder (MDD)

Comparison of Orcinoside With Placebo in Treatment of MDD

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Orcinoside Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in the Chinese Patients with Depression.

NCT ID: NCT02191124 Completed - Clinical trials for Major Depressive Disorder

The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

Start date: June 2011
Phase: Phase 4
Study type: Interventional

In recent years, measurement-based care (MBC) has been gaining more attention in the treatment of depression because it allows psychiatrists to individualize treatment decisions for each patient based on the change of psychopathology and tolerance toward antidepressants. Several studies, such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial using MBC, found that MBC-informed sequential algorithms can be successfully integrated into clinical practice and improve patients' outcomes However, despite a strong theoretical rationale for MBC and data supporting the ability to implement MBC in clinical practice settings, there is currently no randomized controlled trial in MDD patients comparing MBC with usual/standard care. The investigators compare MBC with clinician's treatment decisions, standardizing care to two commonly prescribed antidepressants. Therefore, the aim of this study is to determine the effects of MBC in patients with MDD compared to standard treatment (ST). The research hypothesis is that compared to ST, the estimated time to response and to remission would be significantly shorter in the MBC group without increased dropout rates and side effect burden.

NCT ID: NCT02190968 Completed - Depressive Symptoms Clinical Trials

Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

Start date: March 2015
Phase: N/A
Study type: Interventional

Many patients report residual depressive symptoms despite seemingly successful treatment. With the investigators' previous funding, we developed - Mindful Mood Balance - an online treatment that targets RDS by teaching specific emotion regulation and depression self-management skills that are entirely compatible with antidepressant treatment. The investigators now propose a controlled study to determine whether MMB is more effective than usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery format would provide high fidelity and low-cost empirically supported management of residual symptoms, leading to more robust remission, improved functioning and sustained recovery from MDD over time.