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Depressive Disorder, Major clinical trials

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NCT ID: NCT03556124 Completed - Clinical trials for Major Depressive Disorder

Transcranial Direct Current Stimulation in Major Depression

Start date: February 2, 2018
Phase: N/A
Study type: Interventional

Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective intervention for reducing depressive symptoms. We will investigate these questions in a two-part randomized double blind exploratory clinical trial. The first part of the trial will compare how current flow and functional imaging signal differs in the brain when using tDCS with more focal stimulation, called high definition (HD) tDCS, compared to conventional tDCS (C-tDCS) or sham (non-active) tDCS in patients with MDD. Sixty people with depression (20 in each group) will be randomized to receive either HD-tDCS, C-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham tDCS in the MRI scanner, which will allow us to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests

NCT ID: NCT03555136 Completed - Clinical trials for Major Depressive Disorder

Real-life Effectiveness of Vortioxetine in Depression

RELIEVE
Start date: November 17, 2017
Phase:
Study type: Observational

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

NCT ID: NCT03554447 Completed - Clinical trials for Major Depressive Disorder

Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder

Start date: April 20, 2015
Phase: N/A
Study type: Interventional

This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.

NCT ID: NCT03551288 Completed - Clinical trials for Major Depressive Disorder

Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects

SUVN-911
Start date: May 22, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects

NCT ID: NCT03548675 Completed - Clinical trials for Depressive Disorder, Major

Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)

PITA
Start date: May 23, 2018
Phase: Phase 4
Study type: Interventional

Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels. Compared to patients with a normal metabolization function, for those with increased CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. For those with reduced CYP450 activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. Such evaluation is necessary before broad implementation of these guidelines can be advocated. In the present study 200 patients with sMDD who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). We hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.

NCT ID: NCT03538691 Completed - Clinical trials for Major Depressive Disorder

A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder

Start date: July 13, 2018
Phase: Phase 3
Study type: Interventional

Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term outcomes remains challenging. This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive therapy to protocol-specific open-label antidepressant therapy.

NCT ID: NCT03514810 Completed - Clinical trials for Major Depressive Disorder

Combined Sertraline and Ketoprofen Administration in Major Depressive Disorder

Srt+ktpMDD
Start date: January 10, 2017
Phase: Phase 1
Study type: Interventional

Among the major depressive disorder (MDD) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for MDD. Controls do not take any medicine.

NCT ID: NCT03511599 Completed - Clinical trials for Major Depressive Disorder

Cycloserine rTMS Plasticity Augmentation in Depression

Start date: September 3, 2018
Phase: Phase 1
Study type: Interventional

Transcranial magnetic stimulation (rTMS) is an investigational and therapeutic modality that impacts the connection strength between neurons by delivering patterned energy. In response to this patterned energy neurons fire and adapt by changing their connection strengths. This change in connection strengths is believed to be the underlying mechanism whereby this intervention has therapeutic benefit for this intervention in conditions such as depression. The purpose of this study is to test a means of enhancing the effect of rTMS using a medication (cycloserine) that has been shown to augment and stabilize activity dependent neuronal changes. The investigators wish to use the motor system, where the associated muscle response to brain stimulation can be measured, to probe activity dependent changes in connection strength between neurons.

NCT ID: NCT03504475 Completed - Clinical trials for Major Depressive Disorder

Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers

Start date: March 29, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under fed conditions.

NCT ID: NCT03468686 Completed - Clinical trials for Major Depressive Disorder

The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder

Start date: December 21, 2016
Phase: N/A
Study type: Interventional

Rumination is significantly frequent in major depressive disorder. However, not a lot of studies have investigated the effects of repetitive transcranial magnetic stimulation on rumination and its electrophysiological correlates. This study recruited 61 participants who were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate the potential differences between these stimulation protocols and changes in the behavioral and electrophysiological outcomes after treatment.