Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
Major Depressive DisorderThe overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.
Clinical Validation of a Combinatorial Pharmacogenomic Approach in Major Depressive Disorder
Major Depressive DisorderMajor depressive disorder (MDD) is a common, chronic, debilitating mood disorder causing serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial because of antidepressants ineffectiveness or side-effects. This causes suffering for patients and their families and significantly contributes to pushing up costs for healthcare services. Precision medicine in psychiatry might offer to clinicians the possibility to tailor the treatment according to the best possible evidence of effectiveness and tolerability for each subject. In this context our study aims to carry out a clinical validation of a combinatorial pharmacogenomics (PGx) test in an Italian MDD patient cohort with an advocacy license independence. Our study is a prospective single-blind randomized controlled clinical observational trial enrolling 300 MDD patients. Patients referred to psychiatric services due to the failure and/or the onset of adverse effects of their current treatment for receiving a new antidepressant. Eligible participants with a primary diagnosis of MDD according to DSM-5 criteria and a Hamilton Depression Rating Scale (HAM-D17) with a score > 14 are randomized to TGTG group (Treated with Genetic Test Guide) or TAU group (Treated as Usual). For all subjects, buccal brush for DNA is collected. The primary outcome is the reduction in depressive symptomatology as measured by HAM-D17. The secondary outcomes involve a range of scales that assess MDD symptoms and social functioning outcomes. The assessment is performed at four timepoints: baseline and 4, 8, and 12 weeks. This project represents the first randomized controlled clinical trial in which is tested whether a non-commercial PGx test improves outcomes in a MDD naturalistic cohort. Moreover, the identification of new genetic variants associated with non-response or side effects will improve the efficacy of the test leading to a further cost-saving.
Repetitive Transcranial Magnetic Stimulation in Pharmaco-naïve Patients With Major Depression
Major Depressive DisorderRepetitive transcranial magnetic stimulation (rTMS) has become a safe and efficacious treatment for patients with treatment-resistant depression. In several studies investigating the antidepressant efficacy of rTMS, it has been shown that in low treatment-resistant patients rTMS is more efficacious than in patients where several treatment attempts have failed. Albeit this finding, most studies to date primarily recruited patients with relatively high degrees of treatment-resistance and there is a lack of trials investigating rTMS as a first-line treatment. Therefore, this trials aims to compare the antidepressant efficacy of 4 weeks open-label theta-burst TMS in non-treatment-resistant patients with a comparable group of treatment-resistant MDD patients.
Acupuncture Therapy Based on Biological Specificity of Acupoints for Major Depressive Disorder
Major Depressive DisorderAcupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Therefore, this study is designed to detect the biological specificity of acupoints in healthy participants and major depressive disorder (MDD) participants by using multiple objective assessment tools. And then acupoints that are statistically different between the two groups will be defined as strong reaction points, and other acupoints without statistically different will be defined as weak response points. In addition, this clinical trial will be conducted to explore whether the efficacy of stimulating strong reaction acupoints is more effective than weak reaction points, thereby confirming the specificity of the acupoint.
pBFS Guided VS "5-cm Rule" rTMS Over DLPFC for MDD
Major DepressionMDDThe investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.
Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic...
Major Depressive DisorderThis study will attempt to use magnetic resonance imaging (MRI) to take a picture of the brain to learn about changes that occur in the brain during Transcranial Magnetic Stimulation (TMS) in people receiving this treatment for depression.
Frequency and E-field Enhancement of ITBS for Depression (FREED)
Major Depressive DisorderThe investigators propose a randomized 3-arm double-blinded parallel experimental trial (20 sessions over 4 weeks) in 75 patients with TRD. The three arms include (1) the combination of a fully individualized form of iTBS (using BOTH the frequency and E-field targeting approaches) (Ind-iTBS)), (2) iTBS individualized using E-field targeting only (targeted-iTBS) and (3) Standard iTBS treatment (i.e., typical iTBS localized to the DLPFC using the Beam F3 method). EEG data will be collected at rest and during a working memory task, at baseline, and at the end of treatment along with clinical assessments of depression severity. The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG. The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS. Aim: To evaluate the effects of two individualized forms of iTBS (i.e., using BOTH the frequency and E-field individualization; Ind-iTBS) compared to iTBS individualized for E-field targeting only (targeted-iTBS) and standard iTBS on fronto-parietal theta connectivity. Hypotheses: (1) Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS. (2) Ind-iTBS will also lead to a greater reduction in depressive symptoms (as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores (MADRS)) compared to both targeted-iTBS and standard iTBS.
rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS
MDDMajor Depressive Disorder1 moreTo explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.
Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy...
Generalized Anxiety DisorderMajor Depressive Disorder4 moreThis study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.
Exergames-acceptance and Commitment Therapy Program for Treatment of Major Depressive Disorder
Major Depressive DisorderBackground: The prevalence of depressive disorder, particularly major depressive disorder is on the rise globally and the use of antidepressant medication for treatment does not usually resulting in full remission. However, combination of antidepressant medication and psychotherapy for treatment of major depressive disorder (MDD) increase the rate of full remission compared to antidepressant monotherapy. This three-armed, parallel-group, double-blind, randomized control trial (RCT) aims to assess and compare the effects of combination of exergame and acceptance and commitment (e-ACT) training programme and ACT only on psychiatric symptoms (depression and anxiety), experiential avoidance (EA), quality of life (QoL), and biomarkers of depression (such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF) among MDD patients. Methods: This RCT will recruit 120 patients diagnosed with MDD who will be randomized using stratified permuted block randomization into three groups, which are combined e-ACT training programme, ACT only and treatment-as-usual control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the first assessment before intervention began (t0), second assessment immediately after completion of intervention at 8 weeks (t1) and third assessment 24 weeks after completion of intervention (t2). During each assessment, the primary outcome assessed is the severity of depression symptoms, while the secondary outcomes assessed are severity of anxiety symptoms, QoL, EA, and biomarkers of depression.