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Depressive Disorder, Major clinical trials

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NCT ID: NCT06145594 Recruiting - Clinical trials for Major Depressive Disorder

EMA-Guided Maintenance TMS for Depression

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.

NCT ID: NCT06132581 Recruiting - Clinical trials for Major Depressive Disorder

Causal Role of Delta-beta Coupling for Goal-directed Behavior in Anhedonic Depression

DBA
Start date: January 24, 2024
Phase: N/A
Study type: Interventional

Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.

NCT ID: NCT06131268 Recruiting - Clinical trials for Major Depressive Disorder

The Role of Negr1 In Modulating Neuroplasticity in Major Depression (RONIN)

RONIN
Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

Patients belonging to Group 1 (Major Depression) and 2 (Bipolar Disorder) will be tested with psychometric and functional scales at baseline (T0) and after 4 weeks of pharmacological therapy (T1), to evaluate clinical and functional response to treatment. MDD patients will be screened for the lifetime and recent occurrence of clinically meaningful suicidal ideation and behavior prior to recruitment (-T1). Moreover, in the MDD group, the emergence of clinically meaningful suicidal ideation and behavior will be evaluated at the baseline (T0) and after 4 weeks (T1) by means of the C-SSRS, accordingly to the routine clinical practice. Furtherly, to accomplish the pursues of this research, the two groups will undergo neuroimaging evaluation and a blood collection at the two timepoints for measuring the expression of ncRNA before and after treatment. Meanwhile, a lumbar puncture (LP) for CSF collection will be carried out at the baseline, measuring central levels of Negr-1 and other biomarkers of neurotropism potentially related to the aforementioned role of Negr1 in MDD. Group 3 will be comprehensive of 10 subjects without current or previous diagnosis of psychiatric disorders (healthy controls), who will be evaluated at baseline with psychometric and functional scales, neuroimaging and blood samples collection for ncRNA. Data obtained by the multimodal assessment of HCs at the baseline will be employed as normalization features in the statistical analysis of patients' data.

NCT ID: NCT06130371 Recruiting - MDD Clinical Trials

Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder

Start date: January 4, 2024
Phase:
Study type: Observational

Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women. Stress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity. There are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.

NCT ID: NCT06112652 Recruiting - Clinical trials for Major Depressive Disorder

Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique

Start date: December 4, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders.

NCT ID: NCT06110897 Recruiting - Clinical trials for Major Depressive Disorder

RESISTance Exercise for Depression Trial

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

Depression is a leading cause of disability worldwide and current treatments are ineffective for many people. This trial will investigate the efficacy of a 16-week high vs low dose resistance exercise training program for the treatment of Major Depressive Disorder (MDD) in 200 adults.

NCT ID: NCT06110585 Recruiting - Clinical trials for Depressive Disorder, Major

Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury

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

This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI). The main questions this study aims to answer are: - Does adjunctive TMS reduce psychiatric symptoms in young adults with major depressive disorder and non-suicidal self-injury? - Does adjunctive TMS cause any changes in neuroimaging markers in young adults with major depressive disorder and non-suicidal self-injury? - Does adjunctive TMS cause any effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury? Participants in this study will undergo an extensive clinical evaluation, functional neuroimaging tests (MRI and fNIRS), and peripheral blood collection. They will be randomly assigned to one of two interventions: (1) 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol, or (2) 20 sham sessions using a placebo procedure with the TMS equipment. After the 20 sessions, additional clinical assessments, neuroimaging and blood tests will be conducted. The data analysis will compare the two groups in terms of response and remission of internalizing and externalizing psychiatric symptoms, as well as neuroimaging and blood tests outcomes.

NCT ID: NCT06103760 Recruiting - Clinical trials for Major Depressive Disorder

Positioning of Esketamine Treatment in the Real-world Management of Depression

PoET
Start date: October 31, 2023
Phase: Phase 4
Study type: Interventional

The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: - to investigate whether Esketamine is effective when added to ongoing antidepressant treatment - to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: - attend the clinic for supervised self-administration of intranasal Esketamine treatment - be observed for 2 hours following Esketamine administration including blood pressure monitoring - be asked to complete a battery of questionnaires - be reimbursed for travel expenses

NCT ID: NCT06095778 Recruiting - Clinical trials for Major Depressive Disorder

rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

To 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.

NCT ID: NCT06086366 Recruiting - Clinical trials for Major Depressive Disorder

Presynaptic Imaging in Major Depressive Episodes After COVID-19

PCOV
Start date: August 22, 2023
Phase:
Study type: Observational

The goal of this observational study focuses on understanding and addressing a subset of persistent neuropsychiatric symptoms occurring within 3 months after mild to moderate COVID-19 infection (COVID-DNP). COVID-DNP encompasses major depressive episodes (MDE) with or without additional neuropsychiatric symptoms.