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Depressive Disorder, Major clinical trials

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NCT ID: NCT05450432 Recruiting - Clinical trials for Major Depressive Disorder

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Start date: October 13, 2022
Phase: Phase 4
Study type: Interventional

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.

NCT ID: NCT05441969 Recruiting - Clinical trials for Major Depressive Disorder

In Vivo Cortical Excitability Modulation in Major Depressive Disorder

PDM-TMS
Start date: May 19, 2020
Phase:
Study type: Observational

The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Using TMS to study these mechanisms is performed by applying electromagnetic stimuli to the motor cortex, to obtain measures of temporary cortical excitability modulation. It is known that depressed patients with higher cortical modulation are more responsive to a TMS treatment course. However, it is unknown if there are differences in cortical modulation between depressed patients and healthy subjects. Our goal is to answer this question and contribute towards clarification of the neuroplasticity mechanisms underlying MDD. Accordingly, the investigators will access cortical excitability modulation measures in both depressed patients and healthy volunteers and compare their results. The investigators will also re-assess these measures after 6 weeks of antidepressant treatment. Finally, the investigators will study the association between cortical excitability measures and cognitive processes using an innovative cognitive task.

NCT ID: NCT05439603 Active, not recruiting - Clinical trials for Major Depressive Disorder

ANC-501 in the Treatment of Adults With Major Depressive Disorder

Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (MDD)

NCT ID: NCT05438758 Withdrawn - Clinical trials for Treatment Resistant Major Depressive Disorder

Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study

ZYL-730-02
Start date: January 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)

NCT ID: NCT05437705 Recruiting - Anxiety Clinical Trials

Decoding and Modulating Affective Brain States

Start date: April 21, 2023
Phase: N/A
Study type: Interventional

Generating personalized brain signatures of negative emotion along with personalized brain stimulation protocols to disrupt these patterns. We plan to use fMRI and muscle activity data to determine negative affect maps for each participant. We will then try a variety of patterned repetitive transcranial magnetic stimulation sequences while recording fMRI which will be the basis of two sessions of 3-day individualized brain stimulation designed to reduce negative affect.

NCT ID: NCT05437588 Recruiting - Depression Clinical Trials

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

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

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

NCT ID: NCT05435820 Recruiting - Clinical trials for Major Depressive Disorder

Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser

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

The Near-infrared transcranial laser therapy (NIR-TLT) is a non-ionizing electromagnetic wave. The NIR-TLT is invisible, penetrates the skin and skull into brain tissue and is non-invasive. The benefits of NIR-TLT are wavelength specific. A mitochondrial enzyme, the Cytochrome c oxidase, is the primary chromophore for the NIR-TLT with a wavelength of around 830 nm. When this enzyme is activated, it leads to increased adenosine triphosphate (ATP) production and this event is related to the promotion of cellular plasticity and cytoprotection. These are critical cellular processes for recovery of the depressive patients. Therefore, this study will contribute to answer the question of whether NIR-TLT has an antidepressant effect and whether it is acceptable in minority population.

NCT ID: NCT05435222 Recruiting - Clinical trials for Major Depressive Disorder

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

MSPP-MDD
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

This project aims to evaluate a male-specific psychotherapeutic program (MSPP) for MDD based on cognitive behavioral therapy (CBT). The primary goal is to test the superiority of the MSPP. This will be conducted in two groups of depressed men, namely eudonadal depressed men and hypogonadal depressed men receiving testosterone treatment (TT). In a randomized study design, the MSPP will be compared to a standard CBT and a waitlist control group, resulting in a total of six study groups. Both standardized psychotherapy programs will encompass 18 sessions delivered in a weekly manner, starting at study week 6 and continuing until study week 24. Aligned with the TT-related medical visits of the hypogonadal men, all participants will be followed up with clinical assessments and biosampling at weeks 0, 6, 15, 24, 36. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.

NCT ID: NCT05434156 Recruiting - Depression Clinical Trials

ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

Start date: October 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).

NCT ID: NCT05431374 Completed - Clinical trials for Major Depressive Disorder

Measurement-Based Care Vs. Standard Care for Major Depressive Disorder

MBC
Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

Major depressive disorder (MDD) is one of the leading causes of disability worldwide, indicated as one of the two most disabling mental disorders by the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 (Vos et al., 2020). Despite several effective pharmacological and psychosocial interventions available globally, only about one-third of depressed patients achieve remission (Xiao et al., 2021). There is a need to establish scalable clinical management practices which utilize biopsychosocial assessments, formulate a differential diagnosis, and provide evidence-based treatments for patients with MDD (Hong et al., 2021). While significant evidence for effectiveness of Measurement Based Care (MBC) is found in clinical settings from high and middle-income countries, assessments of MBC compared with usual care for the treatment of MDD are yet to be completed in low-resource settings like LMICs. The aim of this trial is to determine the efficacy and safety of MBC in patients with MDD in comparison with standard care in Pakistan. In order to reduce the variance found in treatment-as-usual and isolate the impact of MBC, standard care for this trial will limit medication choices to either paroxetine or mirtazapine.