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Depressive Disorder, Major clinical trials

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NCT ID: NCT05655507 Recruiting - Clinical trials for Major Depressive Disorder

Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Start date: April 19, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

NCT ID: NCT05652465 Recruiting - Clinical trials for Major Depressive Disorder

Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

Background: Major depressive disorder (MDD) is one of the most impairing medical conditions in the world. Medication and some kinds of talk therapy are standard treatments for teens with MDD, but these do not work well for everyone. Transcranial magnetic stimulation (TMS) has been approved to treat MDD in adults. TMS might help adolescents, too. Objective: To test TMS combined with cognitive behavioral therapy (CBT) in teens with MDD. Eligibility: People aged 13 to 17 years with MDD that has not responded to treatment. Design: Participants will be screened. They will have a physical exam and psychiatric evaluation. They will have an MRI scan and a test of their heart function. They will enroll in 2 NIH protocols (01-M-0254 and 18-M-0037). For 2 to 6 weeks, participants will have weekly CBT, a kind of talk therapy. They will taper off of their psychiatric medicines. For 2 weeks, participants will come to the clinic every weekday. They will receive 3 or 4 sessions of TMS on each of those days. A wire coil will be held on their scalp. A brief electrical current in the coil creates a magnetic pulse that affects brain activity. They will receive 30 TMS pulses in 10-second bursts; these will be repeated 60 times in each 15-minute session. Participants may hear a click and feel a pulling sensation under the coil. They may feel their muscles twitch. Each day, they will have tests of concentration, thinking, and memory. Some may have a 3rd week of TMS. Participants will remain in the study for 5 more weeks. They will begin taking their medications again.

NCT ID: NCT05649293 Not yet recruiting - Clinical trials for Vitamin b6 Level & Depression

Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder

Start date: April 1, 2023
Phase:
Study type: Observational

Estimation of vitamin B 6 levels in diagnosed major depressive disorder patients and their relation to the severity of the disease

NCT ID: NCT05645575 Enrolling by invitation - Clinical trials for Major Depressive Disorder

In-patient SCC TMS

Start date: January 22, 2023
Phase: N/A
Study type: Interventional

The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.

NCT ID: NCT05644301 Not yet recruiting - Clinical trials for Major Depressive Disorder

INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder

INSTA-MD
Start date: January 2023
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.

NCT ID: NCT05644093 Completed - Clinical trials for Major Depressive Disorder

IM and IV SPL026 Drug Product in Healthy Participants

Start date: January 3, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.

NCT ID: NCT05643898 Not yet recruiting - Clinical trials for Major Depressive Disorder

"Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women

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

Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women" Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745). General objective: To assess the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms. Design: A small-scale parallel 2-arms trial will be conducted. Postpartum women with minor or major depression will be randomized to the app-based intervention or waitlist. The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Semi-structured interviews with a sub-sample will provide more information about the participants' experience with the intervention. Women's depression diagnostic status will be assessed at pre-treatment, post-treatment, and 1-month follow-up. Other secondary outcomes will include participants' perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.

NCT ID: NCT05633368 Completed - Covid-19 Clinical Trials

Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy

COVID-M-ECT
Start date: March 31, 2020
Phase:
Study type: Observational

Electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. As relapse after successful ECT is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ECT) or maintenance ECT (more than 6 months after index-ECT) is often necessary to maintain remission. During the current Covid-19 pandemic hospitals redirected resources and closed or significantly diminished ECT services. In this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.

NCT ID: NCT05630963 Recruiting - Clinical trials for Major Depressive Disorder

Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression

Start date: December 29, 2021
Phase:
Study type: Observational

This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.

NCT ID: NCT05630469 Recruiting - Clinical trials for Depressive Disorder, Major

Prediction of Antidepressant Effects of Electroconvulsive Therapy

Start date: December 1, 2022
Phase:
Study type: Observational

Despite its successful use for more than 80 years, the mechanisms of action of electroconvulsive therapy (ECT) are still not fully understood. ECT has been shown to be accompanied by changes in regional brain volumes and connectivity measures, as well as biochemical alterations. However, how these changes relate to ECT response remains to be further elucidated; up to now, there are no objective markers for the targeted use of ECT in clinical practice. Methods: Study design: longitudinal mono-centre study with duration of 36 months. Subjects: 30 depressed patients (aged 18-65 years) eligible for ECT. Measurements: subjects will undergo 2 3-Tesla MRI scans (one before and one after a course of ECT), including structural MRI, resting-state functional MRI, task-based functional MRI and MR spectroscopy. Blood, CSF sampling and clinical assessments will be performed once before and once after the ECT course. ECT: Each patient will be treated in a min. of 8 bitemporal ECT sessions (~4 weeks). Data analysis: Longitudinal changes in brain imaging parameters and laboratory measures (before/after ECT) will be assessed using repeated-measures analysis of covariance. Machine learning with random forests will be employed to identify a pattern of pretreatment imaging, biochemical (serum and CSF) and clinical parameters that are best qualified to predict response to ECT as defined by a reduction of ≥50% of baseline HAMD17. Hypotheses: 1. ECT will be accompanied by changes in brain morphology, functional connectivity, neuronal activation in response to cognitive and reward-related stimuli and neurochemical signals in the brain. 2. ECT leads to changes in blood- and CSF-based markers of neuronal plasticity, neurodegeneration and inflammation, as well as genetic/epigenetic markers. 3. Predictive markers of ECT response can be established based on the relationships between imaging, neurochemical and clinical markers and treatment response. Innovation: This study would be the first to combine multimodal MRI measures with the assessment of biomarkers in the CSF in the context of ECT. The implementation of the proposed trial represents an important step towards a better understanding of the powerful antidepressant properties of ECT. By relating treatment effects and potentially underlying biological mechanisms on numerous complementary levels, the study might help to identify biomarkers that distinguish patients who are likely to benefit from ECT from non-responders. Ultimately, results of the study might be useful in order to establish an individualized medical indication for ECT.