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Depressive Disorder clinical trials

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NCT ID: NCT03977675 Terminated - Clinical trials for Major Depressive Disorder

The Role of HNKs in the Antidepressant Effect of Ketamine

Start date: May 15, 2019
Phase: Phase 1
Study type: Interventional

The objective of the proposed study is to examine the relationship between serum concentrations of HNK and changes in the Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), and the Profile of Mood States (POMS), as well as glutamatergic/GABAergic response. To achieve these aims the investigators propose a double-blind, uncontrolled (no placebo, no healthy control subjects) study with several different doses of ketamine. The investigators will conduct MRI scans to measure Glu and GABA before and during the ketamine treatment.

NCT ID: NCT03953521 Terminated - Depression Clinical Trials

Neuronavigated TBS in Depression

neuronaviTBS
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.

NCT ID: NCT03889756 Terminated - Clinical trials for Major Depressive Disorder

Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy

SAD-KIDS
Start date: July 17, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6 infusions of midazolam in 24 adolescents with treatment resistant depression. The primary outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The second phase is a 6-month open phase in which patients who received midazolam and remain depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All participants will be followed weekly for 6 months and tracked for time to relapse.

NCT ID: NCT03887624 Terminated - Clinical trials for Depressive Disorder, Treatment-Resistant

Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.

Start date: May 21, 2019
Phase: Early Phase 1
Study type: Interventional

This study evaluates the efficacy and safety of ethosuximide in the treatment of refractory depressive disorder in adults. Half of participants will receive ethosuximide and escitalopram in combination, while the other half will receive a placebo and escitalopram.

NCT ID: NCT03887390 Terminated - Depression Clinical Trials

Depression Medication Choice Decision Aid

Start date: July 22, 2019
Phase: N/A
Study type: Interventional

The quality of care for patients facing depression, one of the most prevalent chronic diseases, needs improvement. Despite its high incidence, depression remains sub-optimally managed, particularly in primary care, where most patients suffering from depression receive care. Successfully treated depressive patients can potentially improve their burden of disease and significantly improve their quality of life, but not without the best treatment adapted to their contexts, preferences, and expectations. Clinical research provides essential knowledge for the delivery of quality care which is unfortunately seldom applied in daily practice. One of the preferred methods for overcoming this lack of quality of care is shared decision making: a collaborative process between a clinician and patient that relies on the consideration of scientific evidence, in addition to the values and preferences of the patient. The use of decision aids supports this process by presenting scientific information in an accessible manner while focusing on patient-centered discussion. We developed and rigorously evaluated, in the United States, a decision aid regarding pharmaceutical treatment options for depression, Depression Medication Choice, to be used by health professionals and patients during clinical encounters. The integration and impact of Depression Medication Choice, in primary care practices in a Canadian context is unknown. The specific objectives of this study are threefold: (i) Evaluate the potential impact of the use of Depression Medication Choice by health professionals and patients during clinical encounters on measures of the quality of the decisional process and on health issues important to the patient and health professional; (ii) Document the processes and optimal measures to take to successfully realize projects on a larger scale; and (iii) Evaluate the feasibility of performing patient-centered studies in a realistic context, minimally disturbing to the study environment, in the primary care context in Quebec, Canada. Once completed, the estimated potential impact of this decision aid and shared decision making in primary care in a Canadian context will have been measured, progressing toward high-quality patient-centered care. Moreover, it will be possible to optimally perform future studies in realistic contexts while minimizing the burden on the clinics, their health professionals, and their patients.

NCT ID: NCT03872492 Terminated - Clinical trials for Depressive Disorder, Major

Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale

REDRESS
Start date: October 17, 2019
Phase: N/A
Study type: Interventional

Major Depressive Disorder (MDD) is a debilitating disease characterized by a depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD occurs about twice as often in women than it does in men and affects about 6% of the adult population worldwide each year. Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale, the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression (TRD) occurrence. In parallel, patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression. The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements. It has been demonstrated that an early response to an AntiDepressant (AD) treatment can be seen as early as week 2 and is not related to a placebo-effect. While there is no consensus on the exact cut-off values, several factors emerge as early predictors of a later treatment response, such as: - Improvement in emotional processing of happy facial expressions after 1 week of treatment, - Circa 20% improvement in Hamilton Depression Rating Scale-17 item (HDRS-17) at week 2. The hypothesis is therefore that repeated, systematic and real-time, contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment. REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority, augmented with digital active and passive activity monitoring, speech analysis and emotional processing assessment. Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution. To test this assumption, the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response. The response to treatment at week 6 will be studied (end of Phase 1). Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase (Phase 2). Non-responders will receive another treatment course (Other AD, combination, etc.). Responders will just be followed up and will keep the same treatment. The REDRESS scores will be analysed in this population and will allow us to test the investigator's assumption in people with treatment resistant depression. This study will also allow to assess patients' quality of life at the end of each phase of treatment and to compare results with REDRESS scores.

NCT ID: NCT03845504 Terminated - Depression Clinical Trials

iTBS in Refractory Pediatric Depression

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

This work will mark the first step in understanding the neural targets for rTMS in youth with difficult to treat depressive symptoms, creating benchmarks for optimizing the safety and efficacy of rTMS for pediatric populations through precision targeting, and encourage funding applications for larger sham- controlled randomized clinical studies.

NCT ID: NCT03811041 Terminated - Depression Clinical Trials

Adolescent Depression Associated With Parental Depression

AdoDesP
Start date: March 28, 2019
Phase: N/A
Study type: Interventional

Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care. In children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. It is regularly reported that 30% of adolescents of depressed parents have depression themselves. General Practitioners (GP) have significant access to the depression of adults, potentially parents of teenagers. In fact, 20% of patients in the regular active file of one GP have depression. The primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents. The difficulties of articulation between primary care (PC) and mental health devices are demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and may even disturb early detection of depression. An organized joint between the PC and a specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in PC. In addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. They vary by age and sex of the child but also the sex of the parent. A concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors. AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group of adolescent with PC articulated with mental health service (MDA) and an other group without articulation (routine cares). A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.

NCT ID: NCT03771664 Terminated - Clinical trials for Major Depressive Disorder

A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia

Start date: February 4, 2019
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.

NCT ID: NCT03761030 Terminated - Depression Clinical Trials

L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

Start date: January 9, 2019
Phase: Phase 4
Study type: Interventional

Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.