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NCT ID: NCT06062758 Not yet recruiting - Mental Disorder Clinical Trials

The Efficiency of Simulation-Based Electroconvulsive Therapy Training

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the effect of the simulation-based Electroconvulsive Therapy (ECT) Simulation Training applied to senior nursing students studying at a foundation university on students' perceptions and knowledge levels about ECT. The research hypotheses are as follows; H0: There is no significant difference between students' perception and knowledge levels about ECT before and after simulation-based ECT training to be applied to nursing students. H1: There is a significant difference between students' perception and knowledge levels about ECT before and after the simulation-based ECT training to be applied to nursing students. Type of study: This study was planned in a single group pre-test post-test quasi-experimental design. Participants: The study population will consist of fourth-year students (n=72) of Fenerbahçe University Faculty of Health Sciences, Department of Nursing, Turkish Nursing Program. Intervention: The study will collect data before the students start clinical practice and before the theoretical course on Electroconvulsive Therapy. Then, a one-hour theoretical training on electroconvulsive therapy will be given. This training includes ECT, its history, use areas, nursing care before, during and after ECT and patient education. After the theoretical lecture, a simulation scenario will be distributed to the students, and they will be asked to come prepared on the simulation day. Students will be divided into groups of 15 people, and the groups will be met in the Simulation Laboratory at the determined group hours. Control Group: There is no control group. Outcome: Perceptions and knowledge levels about ECT.

NCT ID: NCT05973643 Not yet recruiting - Clinical trials for Major Depressive Episode

Metabolomics During ElectroConvulsivoTherapy

METECT
Start date: April 30, 2024
Phase: N/A
Study type: Interventional

Investigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.

NCT ID: NCT05699226 Recruiting - Depression Clinical Trials

Amplitude Titration to Improve ECT Clinical Outcomes

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT: H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2). H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency

NCT ID: NCT05655754 Recruiting - Depression Clinical Trials

Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT

Ketofol
Start date: November 1, 2022
Phase: Phase 4
Study type: Interventional

The current anesthetic drug used as standard for ECT procedure at the Department of Psychiatry and Psychotherapy, Medical University of Vienna, is the barbiturate methohexital (Brevital®). As far as we know, methohexital is the most common anesthetic in the procedure of ECT. Only few heterogeneous randomized controlled trials to directly compare the use of (sole) ketamine and methohexital in ECT with relatively small sample sizes have been conducted so far, showing inconclusive findings: a retrospective comparison of methohexital and switch to ketamine anesthesia in 36 patients showed that ketamine prolonged seizure duration and accelerated posttreatment orientation. Others compared both drugs in terms of recovery and reorientation time showing that reorientation time was faster in the methohexital group (total N=9). Another study showed no difference in any outcome measure (depressive symptom improvement, cognition, adverse events) between both groups (total N=16, N=9 per group). Finally, a comparative investigation (total N=37, N=20 vs. N=17) detected no differences between both anesthetics but a higher systolic blood pressure posttreatment and longer motor seizure duration in the ketamine group. A favorable profile of ketamine in regards to seizure quality has been reported, however in terms of outcome measures methohexital and ketamine were similar (total N=50, N=23 vs. N=27). The present study is designed as a prospective randomized non-inferiority trial comparing esketamine plus propofol (ratio 1:1, for better readability from now on referred to as "ketofol") to methohexital, the latter being the current standard anesthetic applied for ECT procedure at our department. Patients eligible for ECT will be randomly assigned to receive anesthesia with either ketofol or methohexital for the whole course of the individual ECT series. Group differences will be investigated both in regards to outcomes related to anesthesia, treatment-outcome and seizure quality. Further, changes in cardiac enzyme levels before and after ECT-treatment and during the entire ECT series will be evaluated and possible group differences will be explored. As stated above the sole/adjunct administration of ketamine as anesthetic agent for ECT has been associated with better seizure quality, similar antidepressant outcomes and anesthesia-associated events, while there is some evidence suggesting that the use of ketamine might present some advantages to other anesthetics in terms of cognitive side-effects accompanying ECT. Therefore, the aim of the present study will be to establish ketofol as a new standard for anesthesia at our Department.

NCT ID: NCT04777110 Not yet recruiting - Depression Clinical Trials

The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Start date: August 2021
Phase: Early Phase 1
Study type: Interventional

A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of non convulsive electroconvulsive therapy Participants: Patients with depression receiving MECT The research drug was esketamine injection The study design was a multicenter, randomized, single blind, parallel controlled trial 25 mg / kg as the experimental group. The normal saline group was the control group (0.05 ml / kg). The sample size was estimated according to the main efficacy index (remission rate) of this study. It was assumed that the remission rate of the esketamine injection group was better than that of the control group. The parameters were set as test level α = 0.05, unilateral, β = 0.8, the cut-off value was 6%, the experimental group: the control group was 1:1, according to the results of previous clinical trials and combined with literature, the remission rate of the control group was 69%, 159 cases in each group, considering the 20% shedding rate, 198 cases in the experimental group and 198 cases in the control group were selected. 1. experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were given electroconvulsive therapy 2. In the control group The patients were given 0.05ml/kg of normal saline, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy Efficacy evaluation 1. Main efficacy indicators Remission rate of depressive symptoms after MECT treatment Remission was defined as two consecutive hdrs-24 scores ≤ 10 after receiving MECT Definition rate of remission rate: the proportion of patients with remission of depressive symptoms in this group

NCT ID: NCT04451135 Active, not recruiting - Clinical trials for Treatment Resistant Depression

CET- REM (Correlating ECT Response to EEG Markers)

Start date: October 9, 2020
Phase: N/A
Study type: Interventional

Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)

NCT ID: NCT04291196 Recruiting - Depression Clinical Trials

Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

PERFECT-VR
Start date: November 27, 2020
Phase: N/A
Study type: Interventional

Lack of patient knowledge about ECT (electroconvulsive therapy) is a leading cause of treatment fear with 60% of ECT patients reporting high levels of anxiety. The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment. In addition, measuring heart rate and blood pressure levels before ECT treatment will allow us to assess changes in anxiety levels. Individuals who choose to participate will be placed (participant will have a 50% chance to be placed in either group) to view either a virtual reality video to experience a virtual ECT session, or to receive standard preparation, i.e. a discussion with a psychiatrist. Before and after this session participants will be asked to complete a measurement of their anxiety level and knowledge about ECT (ECT Attitude & Knowledge Questionnaire). Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments. This study will help to develop a relationship between healthcare providers and patients and their families to help with education before ECT treatment.

NCT ID: NCT03490149 Recruiting - Depression Clinical Trials

Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging

CoEffECT
Start date: January 2, 2018
Phase:
Study type: Observational

The study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated. Therefore, structural, resting-state and diffusion tensor images will be collected within one week before the first and after the last ECT treatment from severely depressed patients. Standard measures of cognitive function and specifically episodic as well as autobiographical memory will also be collected longitudinally and used for prediction. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60 medication-only controls and 60 healthy controls.

NCT ID: NCT03339596 Completed - Clinical trials for Cognitive Impairment

Effects of Erythropoietin for Cognitive Side-effects of ECT

EPO-T
Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

EPO-T aims to investigate (i) whether short-term add-on treatment with erythropoietin (EPO) can reduce cognitive side-effects of ECT and (ii) whether such effects are long-lasting. Further, structural and functional magnetic resonance imaging (MRI) will be used to explore the neural underpinnings of such beneficial effects of EPO. Finally, the trial examines whether potential protective effects of EPO on cognition are accompanied by changes in markers of oxidative stress, inflammation, and neuroplasticity. It is hypothesized that EPO treatment will (i) counteract ECT-induced cognitive decline, accompanied by (ii) increased sub-regional hippocampal volume, (iii) greater memory-related hippocampal activation and reinforcement of dorsolateral prefrontal activity during memory encoding and working memory, and (iv) changes in peripheral markers of inflammation, oxidative stress and neuroplasticity. Furthermore, we hypothesize that add-on EPO-treatment will produce greater, more sustained mood improvement than ECT treatment alone.

NCT ID: NCT03113968 Completed - Depression Clinical Trials

ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

ELEKT-D
Start date: April 7, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures.