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Depressive Disorder clinical trials

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NCT ID: NCT05913401 Recruiting - Clinical trials for Treatment Resistant Depression

Exercise to Augment TMS in Those With Treatment Resistant Depression

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Given the growing evidence that aerobic increases cortical excitability and promotes neuroplasticity, the scientific premise for its potential priming effect on the brain is strong. Combining AE with rTMS may produce a neural environment optimized for a robust physiological effect of rTMS, thereby leading to improved depression outcomes. With positive findings, this study would provide preliminary support for an innovative, safe and feasible approach for improving outcomes for this significant public health problem.

NCT ID: NCT05909267 Recruiting - Clinical trials for Depressive Disorder, Major

Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation

MOTIVADE
Start date: July 26, 2023
Phase: N/A
Study type: Interventional

A large body of evidence on depression heterogeneity point to an "immunometabolic" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.

NCT ID: NCT05907213 Recruiting - Pain, Postoperative Clinical Trials

Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery

Start date: September 25, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.

NCT ID: NCT05902312 Recruiting - Clinical trials for Major Depressive Disorder

Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

ReDeeMD
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are: type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).

NCT ID: NCT05900271 Recruiting - Clinical trials for Treatment Resistant Depression

Dutch-Depression Outcome Trial Comparing 5 Day Multi Daily Neuronavigated Theta Burst Sessions With 6 Weeks rTMS

DDOTT
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression (TRD), whereas remission using a standard 10 Hz rTMS protocol is 25%. The improvement using the SNT protocol is achieved by combining 1) accelerated treatment with multiple sessions per day, 2) applying a higher overall pulse dose of stimulation, using intermittent Theta Burst Stimulation (iTBS), and 3) precise targeting of the region in the left dorsolateral prefrontal cortex (DLPFC), using functional MRI guided neuronavigation. OBJECTIVE To determine if the SNT protocol is more (cost-) effective compared to standard 10 Hz rTMS in patients with TRD, even though the number of pulses given in both protocols is equal, i.e., 90,000. STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks. STUDY POPULATION 108 Patients with TRD (no response to 2 or more evidence-based treatments). INTERVENTION 50 sessions using the SNT protocol in 5 days. The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI. COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard measurement procedures of the skull. OUTCOME MEASURES - Remission, based on the Hamilton depression rating scale - Cost effectiveness, based on healthcare resource use - Quality of life and positive mental health - Tolerability and safety - Relapse - Description of opportunities and difficulties with regard to implementation SAMPLE SIZE The investigators will enrol 108 patients (α=0.05, power is 0.80) including adjustment for attrition. COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare, reduced illness duration and absence from work. TIME SCHEDULE Within 36 months, the investigators will recruit and treat 108 patients with TRD: each center will recruit 9 patients per year. After the last follow-up assessments, the investigators will finalise the study within 12 months and report the results.

NCT ID: NCT05900245 Recruiting - Depression Clinical Trials

Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

Depression is a common clinical mental disease with high incidence rate, high recurrence rate, high suicide rate and high disability rate. As a first-line treatment for depression with refractory, high suicide risk and obvious psychotic symptoms, electric shock has a definite effect on depression, but may lead to cognitive impairment. The induction of extensive epileptiform discharges in the cerebral cortex by electric shock therapy is the key to ensure the treatment effect. The level of epileptiform discharges in the brain is mainly reflected in the quality of convulsions. The quality of electroconvulsive convulsions is affected by factors such as age, stimulation power, anesthetic drugs and depth of anesthesia. Most anesthetics have anticonvulsive properties, such as barbiturate or propofol, which may have a negative impact on the quality of convulsions, thus affecting the therapeutic effect. If the parameters of electric shock, such as stimulation dose, are modified, although the quality and treatment effect of convulsions can be improved, it may also lead to higher cognitive side effects. The depth of anesthesia also affects the quality and efficacy of electric shock convulsions, and the quality of convulsions is higher when stimulated at a shallow level of anesthesia. However, if the use of narcotic drugs is reduced to improve the quality of convulsions, the risk of restlessness and delirium after electric shock may be higher and the comfort of patients may be lower. Therefore, this study compared the effects of different anesthesia induction schemes on the quality and clinical efficacy of electroconvulsive seizures in patients with depression based on EEG monitoring, and explored the optimal depth of anesthesia.

NCT ID: NCT05895747 Recruiting - Clinical trials for Major Depressive Disorder

5-HTP and Creatine for Depression R33 Phase

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

This is a three-armed clinical trial examining the effect of 5-hydroxytryptophan and creatine monohydrate as augmenting agents for the treatment of depression. Subjects will be randomized between 5-HTP 100mg BID + creatine 5g daily, 5-HTP 200mg BID + creatine 10g daily, vs double placebo, for 8 weeks. The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosphorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels.

NCT ID: NCT05894980 Recruiting - Suicidal Ideation Clinical Trials

How to Reduce Suicidal Thoughts and Impulsivity in Depression

DEPIMPULSE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.

NCT ID: NCT05893173 Recruiting - Clinical trials for Major Depressive Disorder

Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Sleep Deprivation

Start date: June 19, 2023
Phase:
Study type: Observational

In the treatment of Major Depressive Disorder (MDD), total sleep deprivation can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as sleep deprivation has been suggested to increase synaptic strength. Although determining how sleep deprivation impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of sleep deprivation. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity, in addition to using a proxy measure, waking EEG theta activity, to assess synaptic strength following total sleep deprivation. Ten individuals (aged 25-50) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging and waking EEG prior to and following approximately 30 hours of total sleep deprivation. Both clinician-administered and subjective mood measures will be collected. It is predicted that sleep deprivation will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.

NCT ID: NCT05892744 Recruiting - Clinical trials for Major Depressive Disorder

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Re-EMBARC
Start date: September 30, 2023
Phase: Phase 4
Study type: Interventional

The purpose of the study is to identify brain biomarkers and characteristics that predict individual responses to treatment of major depression with the antidepressant drug sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI) antidepressant. Our central hypothesis is that brain activity and connections jointly measured with functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) will be able to predict an individual's response to sertraline treatment.