Clinical Research Directory

Transcranial Direct Current Stimulation for Depression

This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.

Effect of Tao Calligraphy Meditation and Energized Water on Depression

The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness and Energized water Practice works to improve Unipolar Depression. The main questions it aims to answer are: * Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the subjective symptoms of Unipolar Depression in adults? * Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the clinical symptoms and signs of Unipolar Depression in adults? * Will any improvement in the John Ware's SF-36 Quality of Life questionnaire, in the Patient Health Questionnaire (PHQ) -9 and in the Beckman Anxiety Inventory (BAI) -21 in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness and energized water practices to their values at six weeks of practice and control groups. Participants will: * be randomized into practice and control groups * complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 6-weeks time point, and at the 12-weeks time point * practice the mindfulness techniques with Tao Calligraphy for a minimum of thirty minutes daily and energized water practice for a minimum of five minutes daily.

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.

Effectiveness of Light Therapy Across Seasons

This study investigates whether the antidepressant effects of bright light therapy (BLT) differ between the spring/summer season and the autumn/winter season in adults with depressive disorders. While BLT is an established treatment for seasonal affective disorder, increasing evidence suggests it may also be effective for non-seasonal depression. However, it remains unclear whether its effectiveness depends on seasonal variation in natural daylight exposure. In this prospective study conducted in a routine clinical care setting, patients referred for depressive symptoms and a score of \> 6 on the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) receive BLT in a structured "Light Café" environment. Participants undergo daily morning light therapy sessions (30 minutes at 10,000 lux) for at least one week, with possible extension up to three weeks based on treatment response. A delayed-start design is used, where a subset of participants begins treatment two weeks later, allowing comparison with the natural course of depressive symptoms. Depressive symptoms are assessed using the QIDS-SR at baseline, during treatment, and at follow-up (6 weeks and 3 months post-treatment). Sleep quality, chronotype, circadian timing, and side effects are also measured. The primary objective is to compare the effectiveness of BLT across seasons. Secondary objectives include evaluating the persistence of treatment effects, assessing the change in sleep quality and day-to-day sleep-wake pattern, and exploring whether outcomes vary by chronotype, circadian phase, and patient characteristics. This study aims to inform whether BLT should be considered a year-round treatment option for depressive disorders and to better understand factors influencing individual treatment response.

Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer

This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.

Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.

Bright Light Therapy for Depressed Geriatric Inpatients

Bright light therapy has been shown to be effective for the treatment of both seasonal and non-seasonal unipolar depression as well as bipolar depression, primarily in outpatients under the age of 60. There is a dearth of studies exploring the efficacy of this treatment modality among elderly depressed inpatients, which is our study population.

Cognitive Enhancement in Unipolar Depression With Yoga

It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population.

Enoxolone in Major Depression - Biomarker-outcome Relationship

Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone/cortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.

Validation of EmoDTx as a Digital Endpoint for Mood Monitoring in Adult Patients Suffering From Unipolar Depression

The aim of this study is to validate the EmoDTx as a digital tool for mood monitoring in adult patients with unipolar depression. The study is prospective, multicenter, and observational, with a single-arm approach. The device studied, EmoDTx, is a mood-monitoring application that analyzes patients' facial expressions to assess their emotional state. The study aims to compare mood scores obtained via EmoDTx with those of standard depression questionnaires (MADRS, PHQ-9, BDI-II, HAMD-17, QIDS-SR16). It will also provide information on how patients feel about the use of passive monitoring software (without the active involvement of the patient) and how the feedback sent to patients can help in their care. Participants who agree to take part in the study, during a selection visit, will be able to: 1. Install the software on a digital interface (smartphone, computer, etc.) and activate or deactivate it whenever they wish during the 8-week follow-up period. 2. Attend scheduled appointments at the center (a first appointment, then a second 4 weeks later, and a final at 8 weeks) to complete a series of questionnaires, be questioned by the doctor, and fill in other questionnaires on their own. 3. At home, answer questionnaires independently, 2 weeks and 6 weeks after the first appointment. 4. The application's feedback will be deactivated during the first 4 weeks and then reactivated during the final 4 weeks. 5. In parallel, an ancillary study will be conducted on 16 patients enrolled in EMC2FR who accepted and performed the video recording of their structured clinical interview following SCID-5-CV at baseline and 4 weeks.

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression

Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.

How to Reduce Suicidal Thoughts and Impulsivity in Depression

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.