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About This Study

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.

Design

Interventions / Regimen

• Other: Electroconvulsive therapy — Electroconvulsive therapy is administered through electrodes positioned bilaterally (bitemporal) or unilaterally (or fronto-temporal) on the frontotemporal region under anesthesia. The stimulation dose is determined by titration method, during the first ECT session. An ECT cure corresponding from 12 to 20 sessions of ECT. Patients will receive 2 sessions a week. Blood samples will be done during the anesthesia process.

Primary Outcomes

• Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR (up to 3 weeks)

About This Study

Psycho-Cardiological Disease studies the complex links between the cardiovascular system and emotions. The two diseases are now the focus of public health organizations, forming a vicious circle of mutual influence. Anxiety and depressive symptoms are three to four times more common in patients with cardiovascular disease than in the general population, and about 15 to 18 percent of patients with coronary heart disease also have major depression, while 25 to 30 percent show significant depressive symptoms. At least 20% of patients with chronic heart failure have some degree of depression. In addition, the probability of cardiovascular events is 2.5 times higher in patients with two hearts, the risk of recurrence of cardiovascular events is heightened, and is strongly associated with higher mortality. At present, the common treatment methods show different advantages and disadvantages, for example, Antipsychotics treatment is a common means of depression/anxiety symptoms, with rapid onset, significant efficacy, wide application and other advantages. However, medications often struggle to fully relieve symptoms, have a high recurrence rate, and can have side effects. Psychotherapy as a traditional intervention method for mental disorders. Its advantages are long-lasting efficacy and no Antipsychotics dependence, but the effect is slower, and patients need to invest more time, energy and financial resources, and the psychological burden is also heavier. In recent years, exercise therapy, as a safe intervention without significant side effects, has been gradually included in a number of international clinical guidelines, and is regarded as the first-line recommended treatment for mild to moderate depression. Research has shown that exercise can effectively relieve anxiety and depression symptoms through a variety of mechanisms, such as lowering cortisol levels, regulating autonomic nervous system function, and reducing stress responses. A study of aerobic exercise in patients with Psycho-Cardiological Disease showed that a 16-week exercise intervention significantly reduced patients' depression scores and significantly improved mood and cognitive function. In addition, it has been validated in multiple studies that exercise can significantly reduce anxiety and depression symptoms by enhancing neuroplasticity, promoting neurogenesis and synaptic remodeling, improving cognitive and emotional regulation. These findings provide a strong theoretical and practical basis for the application of exercise therapy in the comprehensive management of Psycho-Cardiological Disease. The above studies provide important theoretical support for the treatment of biheart disease with exercise, but most studies focus on scale scores, biomarkers, and changes in social behavior. It is well known that antidepressant or anti-anxiety drugs can have many side effects due to their dosage, duration and long-term use, which in turn poses a potential risk to the overall health and…

Design

Interventions / Regimen

• Behavioral: Moderate-intensity continuous movement and Antipsychotics intervention — On the basis of Antipsychotics intervention, Patients in the exercise group should start exercise intervention as soon as possible after completing baseline examination, and need to complete a training plan of at least 36 times, 3 times/week. At the beginning of each training session, patients need to warm up for 5-10 minutes, mainly jogging and stretching exercises. After the warm-up, the patient enters the training phase, the heart rate reserve is 70% to 85%, and after the training, the patient performs 10-15 minutes of recovery exercise, mainly jogging, slow walking and stretching. The specific exercise plan is formulated according to the patients' own aerobic capacity assessment, and the principle of formulation is gradual and individual. At each training session, patients were asked about their perceived fatigue level to adjust the training intensity.
• Drug: Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine) — Patients maintained regular medication during the intervention period, and returned to the doctor every two weeks, and the psychiatrist decided whether to maintain the current dose or gradually reduce the dose based on the patient's symptoms and diagnosis. Psychiatrists, unaware of patient groupings, use supportive measures to help manage adverse reactions.

Primary Outcomes

• Dosage of anti-anxiety/depression drugs (Baseline and after 12 weeks of intervention)

About This Study

Research has demonstrated that psychedelic compounds possess significant therapeutic potential for a variety of disorders, including depression. Despite these findings, the underlying mechanisms driving the therapeutic efficacy of psychedelics remain elusive. Furthermore, there exists a debate over the contribution of the subjective psychedelic experience to their therapeutic benefits. In this study, virtual reality (VR) is utilized as a tool to replicate the subjective experiences induced by psychedelics, aiming to explore their impact on depressive symptoms within a clinical sample. The primary objective of this research is to examine the influence of psychedelic-like phenomenology, as simulated through VR, on depressive symptoms. The study is structured into two distinct arms: the experimental condition features 'Psyrreal,' a VR experience designed to emulate psychedelic effects and the control condition which includes 'Routine Realms,' an analogous VR experience devoid of psychedelic elements. A third waiting list condition may be included, dependent on the availability of sufficient participants and resources. Additionally, the study seeks to identify and analyze various potential mediators that might underpin the therapeutic outcomes observed.

Design

Interventions / Regimen

• Other: Therapeutic Intervention with Psychedelic Virtual Reality — A 55-minute immersive psychedelic virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.
• Other: Therapeutic Intervention with Non-Psychedelic Virtual Reality — A 55-minute immersive virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.

Primary Outcomes

• Change in Emotional State Questionnaire 2 depression subscale score from baseline to follow-up (Measured at 3 time-points - on the day 1 of intervention, and two weeks and two months after intervention.)

About This Study

The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).

Design

Primary Outcomes

• maternal variables (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum)
• infant variables (2 month postpartum, 4 month postpartum, 6 month postpartum)
• perinatal depression (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum)
• breastfeeding situation (2 month postpartum, 4 month postpartum, 6 month postpartum)
• complementary feeding situation (4 month postpartum, 6 month postpartum)

About This Study

The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most. The main questions this study aims to answer are: * Can caregivers complete WeACT as planned? * Do caregivers show improvements in mental health and coping after using WeACT? * What are caregivers' experiences with the program, and what suggestions do they have to improve it? Participants will: * Complete six self-paced weekly online modules and use the daily practice section during the program. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experience.

Design

Interventions / Regimen

• Behavioral: WeACT — WeACT includes six self-paced weekly ACT modules and a tailored daily practice component. Each weekly module includes ACT skills training materials. The daily practice section provides brief, in-the-moment ACT skill coaching based on participants' current self-ratings.

Primary Outcomes

• Enrollment rate (During the recruitment period (up to approximately 6 months))
• Retention (post-intervention assessment completion) (Baseline through post-intervention (approximately 6-8 weeks))
• Core module completion (adherence) (During program participation (~6-8 weeks))

About This Study

Complications after mastectomy include chronic pain and depression.

Design

Interventions / Regimen

• Procedure: Stellate gangalion block — The efficacy of Preoperative ipsilateral stellate gangalion block on the occurrence of postmastectomy depression and pain compared with no block

Primary Outcomes

• incidence of postmastectomy depression (6 months postoperatively)

About This Study

The goal of this study is to test whether combining D-serine with 30 treatments of a) iTBS and b) 18-Hz protocols will enhance clinical outcomes compared to rTMS with placebo (i.e., sugar pill). The investigators hypothesize that NMDA receptor activation via D-serine combined with repeated sessions of rTMS will produce greater clinical outcomes than iTBS with placebo and 18-Hz with placebo.

Design

Interventions / Regimen

• Device: TMS — Subjects will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device plus placebo.
• Drug: D-serine — D-serine, 80 mg/kg, oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks. Dosing is based on maximal plasticity at 80 mg/kg, and clinical dose-finding studies demonstrating that doses between 60 - 120 mg/kg were superior in clinical effectiveness to 30 mg/kg and were safe. Subjects will not be randomized into their TMS group and will either receive iTBS using a Magventure TMS device or 18-Hz H1 TMS using a dTMS Brainsway device. Subjects will have their TMS protocol/treatment determined at the time of consultation according to clinical appropriateness as is the standard of care at the TMS clinic at McLean Hospital.
• Other: Placebo — The placebo is an inactive substance (e.g., lactose or cellulose) packaged to be identical in appearance, taste, and smell to the active study drug. Oral administration, will be advised to be taken 1-hour prior rTMS treatment day (Mon-Fri) for 6 weeks.

Primary Outcomes

• Patient Health Questionnaire 9 (PHQ-9) (Through TMS treatment course, average of 6-8 weeks; taken at treatment #1, #9, #14, #19, #24, #29, and #34, an average of once per week)

About This Study

Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.

Design

Interventions / Regimen

• Device: Wearable activity tracker — Garmin smartwatch will record features, such as activities, heart rate, sleep, through smartphone App

Primary Outcomes

• Development and verification of mood episode prediction algorithm (1 year)

About This Study

This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 weeks.

Design

Interventions / Regimen

• Drug: Ketamine Hydrochloride — Ketamine will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.
• Drug: Placebo — Placebo will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.

Primary Outcomes

• Mean change in depressive symptoms, as measured by MADRS scale (From baseline (day 0) to day 28 (7 days after the last ECT session). A follow-up assessment at Week 12 (90 days) will be included)

About This Study

Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

Design

Primary Outcomes

• Time to clinical worsening (12 months)

About This Study

The purpose of this study is to evaluate the long-term effectiveness and safety of the Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP).Glaucoma patients often have high intraocular pressures (IOP) and need long-term IOP control to prevent loss of visual function and blindness. To date, data on the results of up to 5 years after Hydrus implantation have been published. However, to our knowledge, long-term data over a longer period of time are not yet available. The implementation of this study with a follow-up of the patients after ≥ 8 years (up to 14 years) represents the longest follow-up period to date with a cohort of up to 202 eyes in Mainz, Germany. It enables the collection of "real world data" ≥ 8 years after the Hydrus implantation and provides information about the current status of glaucoma and the effect of the Hydrus implant over this long period (including IOP status, IOP-lowering interventions that have taken place in the meantime, the status of the IOP-lowering medications used, ocular safety, quality of life etc.).

Design

Primary Outcomes

• • Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification (8 years)

About This Study

\[KJ-TFC-005\] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Design

Interventions / Regimen

• Drug: TFC-003 — TFC-003 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).
• Drug: TFC-003-R1 — TFC-003-R1 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).
• Drug: TFC-003-R2+TFC-003-R3 — TFC-003-R2 and TFC-003-R3 will be administered as one drop each into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour) every day. The two eye drops (TFC-003-R2 and TFC-003-R3) will be administered at least 10 minutes apart.

Primary Outcomes

• Comparison between the two groups in the mean change in diurnal intraocular pressure from baseline to Week 12 after 12 weeks of treatment with TFC-003 and TFC-003-R1. (Baseline, 12 weeks)