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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: NCT06136546 Not yet recruiting - Inflammation Clinical Trials

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.

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: NCT06132178 Not yet recruiting - Depression Clinical Trials

Psilocybin rTMS for Treatment Resistant Depression

PSILOBSD
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

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: NCT06126497 Active, not recruiting - Clinical trials for Major Depressive Disorder

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Start date: February 5, 2024
Phase: Phase 2
Study type: Interventional

This is an open-label, parallel-group study to evaluate the safety and efficacy of ropanicant in participants with moderate to severe Major Depressive Disorder (MDD).

NCT ID: NCT06126198 Enrolling by invitation - Clinical trials for Major Depressive Disorder

rTMS Feasibility Study on Adolescent Depression Stimulation

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

NCT ID: NCT06114342 Completed - Clinical trials for Major Depressive Disorder

The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls

Start date: January 10, 2022
Phase:
Study type: Observational

Evidence-based medicine suggests that acupuncture can improve major depressive disorder (MDD). However, the prevalent reliance on experiential acupoint selection lacks scientific underpinning. The investigators conducted a comparative study involving MDD patients and healthy subjects, employing modern techniques to discern biological specificity in MDD-related acupoints. Additionally, the investigators investigated potential correlations between acupoint biological specificity and MDD severity.

NCT ID: NCT06113575 Completed - Clinical trials for Major Depressive Disorder

Practical Application of Accelerated iTBS for MDD

Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The goal of this observational study is to evaluate the feasibility and efficacy of accelerated iTBS in adults diagnosed with Major Depressive Disorder. The main question it aims to answer is: What is the efficacy and tolerability of an accelerated iTBS regimen without radiological imaging in adults who have been diagnosed with Major Depressive Disorder and experience treatment resistant symptoms? Participants will complete 36 iTBS treatments in an accelerated schedule over five days. They will also complete several clinical assessments throughout their enrollment to evaluate their depressive symptoms and response to treatment.