Clinical Research Directory

Lumateperone for Late-Life Depression

The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).

Intramuscular Ketamine for Suicidal Patients in the Evanston Hospital Emergency Department for Suicidal Distress

This pilot study aims to evaluate the feasibility and acceptability of administering intramuscular ketamine for the acute reduction of suicidal distress during psychiatric boarding at the Evanston Hospital ED. This study also aims to identify and describe the broader patient population who present to the Evanston Hospital ED in suicidal distress. This study includes several cohorts. A small (n=8) dosing cohort will receive an IM injection of ketamine. Additionally, an ED staff cohort and a research staff cohort can complete optional surveys to provide feedback about study procedures. Lastly, a chart review will be conducted after the completion of the study to determine the volume and patterns of patients who present to Evanston Hospital ED in suicidal distress.

Neural Correlates of Suicidal Behavior in Youth

This study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response. Participants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments. The study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors. High-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes. The study's primary goals are to: * Identify neural and electrophysiological correlates of suicide risk. * Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide. * Determine how CAMS therapy affects brain function and neurochemistry. By integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.

Adjunctive Probiotic Therapy in Major Depressive Disorder (ProMOOD)

A double-blind, randomized controlled trial (RCT) aimed at evaluating the efficacy of probiotic supplementation in patients undergoing concurrent antidepressant therapy. The study will also assess gut microbiome composition and function, and correlate microbiome changes with clinical and psychological outcomes. Participants will be evaluated by a psychiatrist/clinician, alongside standardized psychological assessments at: * Baseline (inclusion) * Week 4 * Week 12 The following validated instruments will be used: * HAM-D - Hamilton Depression Rating Scale (clinician-rated depression severity) * BDI - Beck Depression Inventory (self-reported severity of depression) * PSS - Perceived Stress Scale (self-reported stress perception) Inclusion Criteria * Age 18-65 years * Confirmed diagnosis of depression according to ICD 11 (International Classification of Diseases) criteria * Written informed consent * Stable antidepressant therapy (same medication for at least 6 weeks to ensure stable clinical response) Exclusion Criteria * Acute suicidality * Severe cardiovascular disease * Pregnancy or breastfeeding * Substance/ alcohol abuse * Severe neurological or systemic disease * Recent antibiotic use * Probiotic use in past year * Treatment resistant depression * Psychotic depression Sample Size * Initial recruitment target: 150-200 participants * Expected dropout rate: approximately 50%, based on similar studies * Final expected sample size: \~100 participants * Sample size calculation based on Nikolova et al., 2023. Primary outcome Change in Hamilton Depression Rating Scale (HAM-D-17) score from baseline to Week 12. Secondary outcomes Change in Beck Depression Inventory-II (BDI-II) score from baseline to Week 12. Change in Perceived Stress Scale (PSS-10) score from baseline to Week 12. Changes in gut microbiome composition and diversity (α-diversity, β-diversity and relative abundance of bacterial taxa) between baseline and Week 12. Safety and tolerability of probiotic supplementation, assessed by adverse events and treatment discontinuation. Intervention: OmniBiotic Stress Repair Microbiome Analysis Subgroup Stool samples will be collected at: * Baseline * 1 month * 3 months Analysis will follow methodologies similar to Mörkl S et al. (2025). Remark: Additional sampling at 1 week (as done in the referenced study) is considered unnecessary, as it falls outside routine clinical monitoring. Antidepressant Strategy * Include patients receiving SSRI (Selective Serotonin Reuptake Inhibitors) and possibly SNRI (Serotonin-Norepinephrine Reuptake Inhibitors) * Advantage: broader applicability * Limitation: increased variability

Activating Voice Journaling for Mental Health With Voice Biomarkers

This retrospective observational study evaluated the relationship between voice characteristics and self-reported mental health symptoms using longitudinal data collected through the Kintsugi Voice Journaling app. Participants provided voice recordings and completed the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) over time. The study analyzed previously collected data to evaluate whether voice biomarkers could be associated with symptoms of depression and anxiety.

Identifying Biomarkers of Response to Digital Interventions for Mood Disorders

The proposed study will be a single-arm pragmatic clinical trial examining the feasibility of online CBT within the CAN-BIND sites and the biomarkers of treatment response to online CBT for mood disorders.

The Medically Tailored Groceries and Mental Health Study

This randomized controlled trial will test whether providing medically tailored groceries for 6 months can improve depressive symptoms among adults with depression and food insecurity. The intervention under study is a 6-month, medically tailored grocery program provided by the Boston-based non-profit organization, Community Servings. Food boxes are mailed to participants' homes every two weeks and are designed by a registered dietitian nutritionists to support an individuals' health needs. Participants may also attend optional nutritional counseling sessions. In this randomized clinical trial, 300 adults with depression and food insecurity will be assigned to one of two groups. The intervention group will receive medically tailored grocery boxes delivered to their home every two weeks for six months (13 boxes total), along with nutritional counseling support. The comparison group will receive usual medical care plus a $30 monthly grocery gift card for six months to be used to purchase any products of their choice. Participants will be recruited from UMass Memorial Health and health centers associated with Community Care Cooperative (C3) in the greater Worcester area in Massachusetts.The main goal of the study is to determine whether the grocery program reduces symptoms of depression. The study will also examine effects on anxiety, food insecurity, diet quality, and healthcare use.

Tracking Risk in Adolescents and Children for Early Identification of Common Mental Disorders

This prospective observational cohort study will enroll approximately 200 children and adolescents aged 7-17 years who are at elevated risk for common mental disorders, including depressive disorders, anxiety disorders, and obsessive-compulsive disorder, based on family history or subthreshold emotional or behavioral symptoms. Participants will be followed for two years. Clinical assessments, questionnaires, EEG, biological samples, and MRI will be collected at scheduled intervals. The study aims to identify factors associated with the onset and progression of these disorders and support early risk identification.

Biomarkers and Pharmacogenomics for Precision Depression Therapy

Background: The clinical management of major depressive disorder (MDD) is hampered by the lack of objective biomarkers and high inter-individual variability in drug response, with conventional antidepressants achieving only a 50% response rate. Objective and Design: This prospective, randomized, parallel-controlled trial aims to enroll 220 MDD patients, who will be allocated 1:1 to either a pharmacogenomics (PGx)-guided therapy group (treatment selection based on genetic testing) or a conventional treatment group (treatment as usual per guidelines), with a 12-week follow-up. Additionally, a matched healthy control cohort will be included for cross-sectional biomarker comparisons. Intervention and Outcomes: Patients in the PGx group undergo buccal swab testing for key genetic polymorphisms (e.g., CYP2D6, CYP2C19) to inform antidepressant type and dosage. The primary outcome is the 12-week response rate (≥50% reduction in HAMD-17 score from baseline). Secondary outcomes include remission rate, incidence of adverse drug reactions, and medication adjustment frequency. Exploratory Aims: Multidimensional baseline data-including resting-state fMRI (VMHC), peripheral blood biomarkers (inflammatory cytokines, thyroid function, BDNF), urinary metabolites, and gut microbiome-will be integrated to construct a predictive model for treatment efficacy and to identify novel MDD biomarkers. Scientific Significance: This study seeks to validate the clinical utility of PGx-guided prescribing and to advance the shift from symptom-based diagnosis towards a biological-characteristic-based precision medicine framework for depression.

Augmented Depression Therapy (ADepT) Case Series

This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care. ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly. As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.

Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms

Many Asian Americans with depression also struggle with physical symptoms-such as pain, fatigue, or other forms of bodily discomfort-that occur at the same time. Right now, there is no proven treatment that effectively addresses both the depression and these physical symptoms together. This study will test whether it is practical, acceptable, and safe to combine the Stress Management and Resiliency Training (SMART) program with meditative movements for people who have both major depression and these distressing physical symptoms.

Intern Health Study 2026

The aim of this study is to evaluate the efficacy of using a reinforcement learning algorithm to determine the optimal content of a mobile health intervention (message delivered via smartphone) for improving the mood, physical activity, and sleep of medical interns.

The Effectiveness of a One-stop Electronic Clinic for Psychological Service (eClinic) in Hong Kong

With an increasing need for effective and accessible mental health services, telepsychology can be one promising solution to narrowing the gap between demand and supply. Our one-stop electronic clinic of psychological service (eClinic) aims to deliver evidence-based treatments to individuals with moderate to severe emotional disorders of various kinds in Hong Kong. This study examines the cost-effectiveness and cost-efficiency of a hybrid model of telepsychology, in which contact with therapists focuses on facilitating service users' self-learning based on our online interactive modules. Results will shed light on the benefits of telepsychology to promoting access to mental health services in Hong Kong.

Brain Imaging of Cognition Inn Schizophrenia and Depression

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, brain imaging is used to investigate the brain mechanisms underlying these cognitive deficits in these populations.