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NCT07553130
Major depressive disorder (MDD) and anxiety are increasingly prevalent among university student populations, yet early detection remains reliant on psychometric instruments tied to diagnostic criteria (e.g., PHQ-9, GAD). Emerging evidence suggests that depression affects both the acoustic properties and content of speech, making speech analysis a promising candidate as a digital biomarker for early screening. This study evaluates the validity of acceXible, a speech-based machine learning platform, for the detection and monitoring of depression and anxiety in the student population of the Benemérita Universidad Autónoma de Puebla (BUAP), Mexico. AcceXible captures spontaneous speech through open-ended interview tasks and applies automated acoustic and linguistic analysis. The primary objective is to evaluate the validity of the acceXible spontaneous speech analysis system for depression and anxiety screening, assessed against the PHQ and GAD scales as reference standards. Secondary objectives include examining associations between speech-derived variables and other study measures, evaluating participant engagement with digital mental health resources, assessing user satisfaction with the platform, and analyzing longitudinal changes in scores across follow-up assessments.
NCT04814355
Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of patients achieving remission. This may be because monoamine dysfunction is not the primary pathophysiology in all MDD patients. One avenue for the development of novel MDD treatments is through anti-inflammatory drugs; MDD is linked to a pro-inflammatory phenotype characterized by microglial activation, leading to the release of pro-inflammatory cytokines and upregulation of cellular markers including cyclooxygenase-2 (COX-2) and translocator protein (TSPO; a protein located on the outer membrane of microglia). Relevant to this proposal, TSPO can serve as an in vivo marker of neuroinflammation using the newly developed positron emission tomography (PET) tracer for TSPO, \[18F\]FEPPA. In support of this, a recent \[18F\]FEPPA PET study found that MDD patients in a current major depressive episode (MDE) had significantly higher TSPO binding in the prefrontal cortex (PFC), anterior cingulate cortex (ACC) and insula, relative to healthy controls. The prefrontal cortex and ACC are both implicated in mood regulation whereas the insula is involved in interoceptive signaling, which is known to be abnormal in MDD. Celecoxib, a selective COX-2 nonsteroidal anti-inflammatory drug (NSAID), is a promising new treatment for neuroinflammation in MDD. Clinical studies have observed that, in a subset of depressed patients, celecoxib treatment reduced depression severity as assessed by the Hamilton Depression Rating Scale (HDRS). While these findings demonstrate that celecoxib reduces symptom severity, PET imaging technology is critical for understanding how celecoxib affects the underlying pathophysiology of depression. Here, the team will investigate neuroinflammation as an underlying pathology in depression and test whether neuroinflammation is reduced by celecoxib in MDD patients. Specifically, in the proposed pilot study, MDD patients in a current MDE will receive \[18F\]FEPPA PET scans prior to and following 8 weeks of treatment with 400mg/day of celecoxib, with HDRS scores obtained at each time point. The investigators hypothesize that following celecoxib treatment, patients will show a significant reduction in neuroinflammation in the PFC, ACC and insula, which will correlate positively with the reduction in depressive symptoms, as measured by the HDRS. The proposed study will use novel imaging technology, \[18F\]FEPPA PET, to measure the effects of celecoxib on neuroinflammation in MDD patients. Our results will help to 1) identify neuroinflammation as an underlying pathology in MDD and 2) test whether reduction of inflammation is the mechanism of action of celecoxib. As such, the results of this study will aid in the development of targeted clinical treatments to improve remission rates in MDD patients.
NCT07373535
The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how people respond to psilocybin treatment. The main questions it aims to answer are: * Is it feasible to conduct a patient-preference randomized trial of psilocybin-assisted psychotherapy? * Does receiving a preferred psychotherapy style improve treatment experiences or outcomes? * How do music-centered and mindfulness-centered PAP approaches compare in their effects on improving mood and well-being? Researchers will compare music-centered PAP to mindfulness-centered PAP to see if aligning psychotherapy with individual preferences is a practical and potentially beneficial approach for improving treatment efficacy and tolerability. Participants will: * Be adults with treatment-resistant depression * Receive two 25 mg psilocybin (PEX010, Filament Health) sessions, spaced four weeks apart * Experience one session with music-centered psychotherapy and one with mindfulness-centered psychotherapy * Before treatment, rate their preference for the two psychotherapy approaches * Be randomly assigned to receive their preferred or non-preferred approach first, followed by the other * Complete preparation and integration sessions before and after each psilocybin session This feasibility trial will also collect information on participants' cultural and personal factors influencing psychotherapy preferences using a modified Cultural Formulation Interview, and explore physiological measures of therapeutic alliance, an important factor in psychotherapy outcomes.
NCT06391593
The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days. Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
NCT06655623
This clinical multiple case study seeks to expand the knowledge of how schema therapy could function as an intervention for difficult-to-treat depression. The study will explore in depth the course of a 30 session treatment with schema therapy conducted over approximately one year on three individual patients at two different psychiatric treatment sites. Together, the data from this study will inform about the feasibility of schema therapy for difficult-to-treat depression as well as form the base for recommendations in adapting schema therapy for this particular patient group.
NCT07533773
Against the clinical backdrop of the growing global burden of neuropsychiatric disorders, the rapid rise in depression prevalence, and the frequent association of these conditions with cognitive impairment, this study highlights the limitations of current cognitive assessment tools-such as their time-consuming nature and lack of specificity-and underscores the urgent need to develop simple and efficient assessment methods. In terms of treatment, modified electroconvulsive therapy (ECT) and magnetic seizure therapy (MST) are rapidly acting neuromodulation therapies; however, their effects on cognitive function and underlying brain mechanisms remain controversial, and there is a lack of direct comparative studies. Functional near-infrared spectroscopy (fNIRS) technology can non-invasively monitor changes in cerebral hemodynamics, providing a powerful tool for assessing brain function before and after treatment. Therefore, this study aims to combine resting-state and task-based fNIRS with multidimensional cognitive and emotional assessments to systematically compare the effects of ECT and MST on frontal-temporal cerebral hemodynamics. We seek to clarify the differences in brain function regulation between the two treatment modalities and their association with improvements in cognition and mood, with the goal of providing scientific evidence to elucidate the brain mechanisms underlying neurostimulation therapies and optimize individualized treatment plans.
NCT07523048
This study will look at how a new medication (dextromethorphan and bupropion taken together in one pill) affects the brain in people with depression. All participants will take the medication for two weeks and have brain scans done. Since people with depression often feel reduced enjoyment in day-to-day activities, our goal is to learn if this treatment can change brain activities in ways that could help improve mood and enjoyment in life.
NCT05966532
This is a cross-sectional pilot study designed to establish hot and cold cognitive functions and underlying neurocircuitry in older adults with MDD. The investigators will study 120 participants aged 21-80 years old with MDD. All participants will undergo clinical and neurocognitive assessment, and Magnetoencephalography (MEG)/Magnetic resonance imaging (MRI) procedures at one time point. The investigators will also enroll 120 demographically matched comparable, never-depressed healthy participants (controls) to establish cognitive benchmarks. Healthy controls will complete clinical and neurocognitive measures at one time point. To attain a balanced sample of adults across the lifespan, the investigators will enroll participants such that each age epoch (e.g., 21-30, 31-40, etc.) has a total of ten subjects (n=10) in both the healthy control cohort and depressed cohort.
NCT04120285
We propose to carry out a treatment experiment in which we evaluate the extent to which randomizing primary care clinicians have access to remote internet-based Cognitive Behavior Therapy (eCBT) in rural West Virginia (WV) and Kentucky (KY) will help improve treatment of patients with Major Depressive Disorder (MDD). WV and KY are two of the most rural states in America and mental health treatment resources are low; especially in rural parts of the state.
NCT07226661
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
NCT06480201
The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.
NCT07115329
The goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel1)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.
NCT07484789
Major depression is a mental illness that seriously threatens public health, leading to disability, reduced quality of life, economic burden, and premature death. It is estimated that 18.4% of the world's population lived with depression between 2005 and 2015, and it is projected to be a leading cause of global disease burden by 2030. Major depressive disorder manifests with symptoms such as decreased interest and desire, a depressed mood, increased or decreased sleep and appetite, feelings of worthlessness and guilt, decreased energy, suicidal thoughts and attempts, leading to significant impairment in functioning. Choosing the appropriate treatment for depression and taking measures to improve the individual's functionality quickly, shorten hospital stays, and reduce the number of hospitalizations are crucial. In addition to pharmacological treatment, clinical guidelines recommend the combined use of pharmacological and psychosocial interventions in the treatment of depression. The mindfulness-based cognitive therapy, which forms the basis of the psychoeducation planned for this study, was developed as an 8-week group approach. Theoretical studies examining emotion regulation mechanisms have indicated that mindful awareness is a fundamental mechanism for emotion regulation. The literature suggests a negative correlation between mindful awareness and the severity of depressive symptoms and difficulty in emotion regulation. Furthermore, despite numerous descriptive, correlational, and experimental studies on major depression, no studies have been found demonstrating the effect of mindful awareness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in patients diagnosed with major depression. This study, therefore, differs from existing research and will make a significant contribution to the literature.
NCT06793397
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
NCT06340958
The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.
NCT06550037
OPADE is a non-profit, observational, multicenter, open-label study aimed at defining personalized treatment for Major Depressive Disorder (MDD). In particular, we will combine genetics, epigenetics, microbiome, immune response data together with anamnesis, questionnaires, electroencephalography (EEG) collected from subjects suffering MDD. Eventually, an Artificial Intelligence (AI)/Machine Learning (ML) predictive tool will be created to guide clinicians in improving MDD treatment and patient's stratification.
NCT07474974
This research explores the potential of retinal ganglion cells (RGCs), particularly intrinsically photosensitive RGCs (ipRGCs), as biomarkers for predicting response to transcranial magnetic stimulation (TMS) in treatment-resistant depression (TRD). We also aim to assess the impact of TMS treatment on RGCs and ipRGCs in TRD patients, investigating associations with clinical improvements and cognitive status. A clinical trial involving 44 patients with treatment-resistant depression (TRD) will be conducted. All participants will receive rTMS targeting the dorsolateral prefrontal cortex (DLPFC). Data will be collected pre- and post-intervention, as well as at a 2-month follow-up, using multiple outcome measures, including the post-illumination pupil response (PIPR). The project seeks to confirm the effectiveness of TMS and the potential of RGCs/ipRGCs as predictors of treatment response, thereby facilitating the development of personalized treatment strategies for TRD patients undergoing rTMS therapy.
NCT04981561
To evaluate the safety and tolerability of single ascending doses of zelquistinel in normal human volunteers
NCT01743716
This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.
NCT07025720
The goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (TMS) can help people with depression and suicidal thoughts. The treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (MRI) to guide which part of the brain to target. This study tests whether this treatment is a helpful and practical option for adolescents and young adults who are depressed and have suicidal thoughts. We want to see if: 1. This treatment is feasible and acceptable to patients 2. It can reduce depression and suicidal thoughts 3. It can lower the chance of going to the hospital 4. It affects daily functioning (school, work, relationships) All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.