Clinical Research Directory

Pharmacogenetic-Guided Antidepressant Treatment in Depression

The purpose of this clinical trial is to evaluate whether using pharmacogenetic testing to guide antidepressant treatment can improve outcomes in adults with major depressive disorder in Morocco. Depression is a common mental health condition, and finding the most effective antidepressant for a patient can take time. Some individuals do not respond well to the first medication prescribed or may experience side effects. Pharmacogenetic testing examines genetic variations that can influence how a person processes certain medications. Information about genes involved in drug metabolism, such as CYP2D6 and CYP2C19, may help clinicians choose antidepressants and adjust doses more appropriately for each patient. The main question this study aims to answer is whether treatment guided by pharmacogenetic test results leads to higher remission rates of depressive symptoms compared with usual clinical care. In this study, participants diagnosed with major depressive disorder will be randomly assigned to one of two groups. In the pharmacogenetic-guided group, clinicians will receive the patient's genetic test results and may use this information to guide antidepressant selection and dosing. In the usual care group, antidepressant treatment will be prescribed according to standard clinical practice without access to pharmacogenetic information. Participants will receive antidepressant treatment and will be followed for 12 weeks. During this period, depressive symptoms will be evaluated using standardized clinical questionnaires, including the Patient Health Questionnaire (PHQ-9). Information on treatment response, medication tolerance, and adverse effects will also be collected. This study aims to provide evidence on the potential role of pharmacogenetic-guided treatment in improving depression management and to support the development of personalized medicine approaches in psychiatric care in Morocco.

Deaf CBT-TS to Reduce Suicide Risk

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes. The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care. Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Brief Trial of ACT-i for Adults With Chronic Insomnia

This is a prospective, randomized-controlled trial that assesses the efficacy of a brief Acceptance and Commitment Therapy (ACT-i), compared to an attentional control group, in adults with chronic insomnia. The interventions will be evaluated for their impact on insomnia severity, cognitive function, depression, anxiety, psychological flexibility, and sleep beliefs - measured before treatment, two weeks after and at a three-month follow-up.

Implementing Action-Based Cognitive Remediation for Transdiagnostic Cognitive Difficulties in a Tertiary Mental Health Hospital

Psychiatric conditions are each defined by different set of symptoms, however, they often share common characteristics such as impairments in cognitive and social functioning. These impairments can cause significant distress and disrupt daily functioning by preventing individuals from actively participating in school or work, maintaining healthy relationships with others, and engaging in everyday activities independently. The goal of this clinical trial is to examine if action-based cognitive remediation (ABCR) therapy, a type of cognitive training program, works to treat cognitive impairments in participants with psychiatric disorders. The main questions it aims to answer are: * Whether the intervention will improve the thinking skills of participants with different types of psychiatric conditions * Whether the intervention will improve social skills and work performance * Can this program be easily used in a regular hospital, and do the people who take part in it find it helpful and worth their time * Whether the improvements from the intervention last for a long time after the training is over. Researchers will compare how much the thinking skills of participants change during an 8-week waiting period (where they get no treatment) to how much they change during the 8-week training program to see if the training makes a bigger difference in helping them think and live better. Participants will : * Complete a series of questionnaires on memory, thinking skills, and mental health at the beginning of the study * Wait 8 weeks without any intervention or training * Complete the series of questionnaires again * Complete an 8-week training intervention of ABCR where they will use special computer programs to practice real-life skills and tasks like planning a meal or making an appointment * Complete the series of questionnaires and an additional structured interview to assess acceptability and feasibility of the intervention. * 3 month later, complete questionnaires for a final time.

Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine

This project aims to integrate digital phenotyping and AI-driven iCBT into a comprehensive platform for MDD diagnosis and treatment in Taiwan. The study will explore dynamic, real-time behavioral and physiological markers to refine diagnostic classifications and optimize personalized therapeutic strategies.

Enhancing Slow Wave Sleep in Depression

The goal of this pilot study is to determine if non-invasive brain stimulation during sleep can increase deep sleep in adults with depression. It will also determine if increased deep sleep improves cognitive performance and mood ratings. Participants will be asked to wear a non-invasive device that records their brain activity and delivers transcranial electrical stimulation during sleep. Participants will also wear an actigraphy watch that measures activity levels throughout the study. In addition, participants will complete several cognitive assessments and mood and sleep questionnaires throughout the study.

IMST for Dementia Risk Reduction

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Nutritional Intervention for College Students With Depression

The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are: * Nutritional content, meal timing, and sleep patterns in college students with depression * Feasibility of nutritional interventions (Mediterranean Diet and Time-Restricted Eating + Mediterranean Diet) in college students with depression Researchers will compare two groups - Mediterranean Diet (Med-Diet) and Time-Restricted Eating + Mediterranean Diet (TRE + Med-Diet) - to assess adherence to the dietary interventions and overall feasibility of the study procedures. Participants will: * Complete a 2-week baseline logging diet, sleep, activity, and mood * Be randomized to Mediterranean Diet (Med-Diet) or Time-Restricted Eating + Med-Diet (TRE + Med-Diet) * Participate in dietary counseling with a registered dietitian during the 8-week intervention * Continue to log diet, wear an actigraphy device, and complete mood, sleep, and diet assessments throughout the intervention

Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects

The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1. Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all participants). 2. Test effects of psilocybin on brain network complexity measures during the hedonic experience using fMRI as a correlate for prohedonic (anti-anhedonic and well-being increasing) effects. 3. Elucidate relevance of the psychedelic experience to these effects (clinical, behavioral, and imaging) in a pharmacological challenge using the 5-HT2A/D2 antagonist risperidone and extensive characterization of the psychedelic experience. Secondary Objectives 4. Test the differential effects of the psychedelic experience on fMRI paradigms measuring symptoms shown to be altered in anhedonia, more specifically reward processing and sexual arousal. 5. Test the relevance of neuroplasticity (BDNF) and inflammatory parameters to anti-anhedonic, well-being promoting, and brain network dynamic complexity effects. 6. Test the effects of the psychedelic experience on BDNF and inflammatory parameters. Researchers will compare the effects of psilocybin in two separate sessions (one with psilocybin alone, one with co-administration of risperidone) in both patients with depression and anhedonia and healthy control participants. Participants will: * Take 25 mg of psilocybin p.o. in two sessions, in one of the two sessions they will take 1 mg risperidone p.o. before ingestion of psilocybin, to block psilocybin's acute psychedelic effects. * Undergo 3 MRI sessions, one before the first psilocybin session ('baseline') and one session each on the day after each respective psilocybin session. * Perform a variety of tasks during each fMRI session to asses the treatment's effects on anhedonia.

Sham-Controlled Rapid-Acting Neuromodulation for Depression

The goal of this study is to learn whether 5 days of accelerated intermittent theta burst stimulation (iTBS), a rapid form of transcranial magnetic stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate brain activity, works to treat depression in adults. The main questions it aims to answer are: * Does accelerated iTBS reduce depressive symptoms compared to sham (placebo) stimulation? * Are there measurable brain, biological, and digitally measured emotion changes associated with treatment response? Participants will: * Be randomly assigned to receive either active iTBS or sham stimulation * Receive 10 stimulation sessions per day for 5 consecutive days (total of 50 sessions) * Complete MRI brain scans and EEG recordings before and after treatment * Provide blood and saliva samples to measure biological markers * Complete depression rating scales and questionnaires at baseline, during treatment, and at follow-up visits * Use a secure mobile app to record brief facial and vocal samples during the 5-day treatment and at follow-up visits * Return for follow-up visits at 1 week and at 1, 3, 6, and 12 months after treatment

Dynamic Networks in Depression Treatment: Mechanisms of Change in Pharmacological, Psychological and Combined Treatment of Depression

This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions. By applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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.

Effect of Mindfulness-based Psychoeducation in Depression

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.

Global Collaborative Research on Establishing a Korean Cognitive Aging Cohort

The goal of this observational study is to learn how daily emotional stress affects cognitive function and inflammation in community-dwelling older adults aged 60 and older in Seoul, Republic of Korea. The main questions it aims to answer are: Does daily psychological stress measured in real-time affect short-term and long-term cognitive function in older adults? Do pro-inflammatory cytokines (such as CRP, IL-6, IL-10, and TNF-α) mediate the relationship between emotional stress and cognitive decline? How do social support and social isolation influence cognitive function and inflammatory biomarkers over time? Participants will: Complete baseline surveys assessing depression, cognitive function, and personal characteristics Use a smartphone app to answer brief surveys about their emotions, cognitive performance, and social interactions 1-6 times daily for two weeks Wear a Galaxy Watch to track sleep quality, heart rate, and physical activity Provide blood samples for inflammatory biomarker analysis Return for follow-up assessments at 6 months and 1 year This study is part of an international collaboration to establish a Korean cohort comparable to the U.S. Einstein Aging Study, with the aim of developing culturally tailored dementia prevention strategies.

TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children

Depression in childhood and adolescence is a serious and increasing public-health problem associated with profound short- and long-term consequences, including impaired social and educational functioning, increased risk of somatic illness and substance use, and elevated mortality from suicide. Up to half of depressive disorders beginning in youth persist into adulthood, and the COVID-19 pandemic, with its attendant social isolation, has further increased the incidence of clinically significant depressive illness in children and young adults. Despite the high burden of disease, pharmacotherapeutic guidance for pediatric depression remains limited. Selective serotonin reuptake inhibitors (SSRIs) are first-line agents, yet dosing recommendations for youth do not adequately account for major sources of variability such as developmental pharmacokinetics, body size, age, comorbid diagnoses, and pharmacogenetic differences. Fluoxetine is commonly recommended in pediatric populations largely for historical reasons, while newer SSRIs such as escitalopram and sertraline are increasingly prescribed off-label without robust comparative evidence. This randomized clinical trial evaluates therapeutic drug monitoring (TDM)-guided treatment with fluoxetine, sertraline, or escitalopram in children and adults diagnosed with Major Depressive Disorder. TDM procedures will be implemented across all randomized arms to capture drug exposure and enable dose adjustments according to predefined safety and efficacy criteria. Treatments will be initiated at the lower end of recommended pediatric doses and titrated if prespecified clinical nonresponse or tolerability thresholds are met, allowing evaluation of dose-response dynamics while prioritizing patient safety. The study combines prospective, randomized comparative effectiveness methodology with intensive pharmacokinetic/pharmacodynamic (PK/PD) assessment. Repeated plasma concentration measurements will be collected at multiple timepoints to characterize within- and between-patient PK variability for each SSRI. Standardized clinical instruments will be used longitudinally to assess depressive symptom severity, response and remission rates, time to onset of therapeutic effect, adverse events (including early activation and worsening of suicidal ideation), treatment adherence, and functional outcomes (academic performance, social functioning, and quality of life). Pharmacogenetic testing will be performed to evaluate the contribution of genetic variants (including but not limited to CYP enzymes, serotonin transporter and MAO-A related polymorphisms) to PK parameters and clinical response. Integrated population PK and PK/PD modeling will (1) quantify concentration-effect and concentration-adverse-effect relationships over time, (2) identify demographic, clinical and genetic moderators of exposure and response, (3) evaluate nonlinearity in PK (e.g., dose-dependent absorption or clearance patterns), and (4) derive evidence-based therapeutic concentration ranges and individualized dosing algorithms for pediatric practice. Secondary objectives include head-to-head comparison of efficacy, tolerability, time to response, and persistence on treatment between the three SSRIs, as well as exploratory analyses of diagnostic subtypes and comorbidities that may influence outcomes. By filling critical gaps in controlled PK/PD data for the most commonly prescribed SSRIs in youth, this trial aims to move beyond meta-analytic inference toward actionable, individualized dosing recommendations. The expected outcomes are earlier identification of atypical pharmacokinetics, safer and more effective dose optimization, reduced adverse events and early discontinuation, shortened time to symptomatic improvement, and ultimately improved functional recovery and quality of life for children and young adults with depression. The study's translational PK/PD outputs will inform clinical TDM protocols, pediatric dosing guidelines, and future precision-medicine strategies in adolescent psychopharmacology.

Efficacy and Mechanisms of Escitalopram in Drug-Naïve First-Episode Major Depressive Disorder

The goal of this project is to quantify the effectiveness and safety of escitalopram oxalate oral solution in the treatment of first-episode, drug-naïve patients with major depressive disorder, and to explore the mechanisms underlying its antidepressant effects using multi-omics approaches. By integrating clinical, cognitive, laboratory, imaging, genetic, and environmental data, the study aims to identify patient subgroups who are most likely to benefit from escitalopram, thereby promoting individualized and precision treatment for depression. This multicenter, prospective, single-arm intervention study will enroll 200 adults aged 18-65 years with major depressive disorder, who will receive escitalopram oxalate oral solution for 8 weeks. Depressive symptoms, cognitive function, and adverse events will be assessed at baseline, during treatment, and after 8 weeks of treatment to evaluate efficacy and safety. Escitalopram blood concentrations will be measured at week 4 to monitor treatment adherence and support safety evaluation. Through comprehensive data collection and multimodal analysis, this project seeks to clarify the biological mechanisms of escitalopram and provide evidence to guide more precise clinical use of antidepressant therapy.

ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder

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.

Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot

This pilot study evaluates the feasibility and acceptability of implementing a Behavioral Health Collaborative Care Model (BH CoCM) for family members of ICU survivors. The intervention includes telehealth-enabled behavioral health assessments and access to the NeuroFlow platform. A subset of participants will undergo qualitative interviews.

Behavioral Health Collaborative Care Model in an ICU Recovery Clinic

Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.

Open-Label Psilocybin Study in Transdiagnostic Population

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Using Integrated Care and Wearable Technology to Evaluate Outcomes of the Shields & Stripes Program for Veterans and First Responders

This study aims to evaluate outcomes from the Shields \& Stripes (S\&S) program - a 12-week, multidisciplinary wellness intervention designed for veterans and first responders. The S\&S program integrates occupational therapy (OT), mental health (MH), physical therapy (PT), and registered dietitian (RD) services to promote recovery, resilience, and performance in individuals who have experienced cumulative stress, trauma exposure, or occupational burnout. This research will use a retrospective mixed-methods observational design to analyze data collected from previous S\&S participants who consent to research use of their de-identified information. No intervention or treatment changes will occur as part of this study. Quantitative data will include biometric information (e.g., sleep, activity, and heart rate variability via Oura Ring), standardized self-report measures (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), satisfaction surveys, and laboratory nutrition panels. Qualitative data will include semi-structured interviews with consenting participants and S\&S providers following program completion. The purpose of the study is to identify patterns of improvement in physical, psychological, and occupational functioning and to explore how integrated, team-based care supports holistic recovery. Findings may inform the development of future evidence-based wellness programs for military and first-responder populations. Participation involves minimal risk, and all data will be de-identified before analysis.

Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping.

The study protocol was submitted to ERA-NET NEURON for funding on 28/06/2023. Description of the Israeli responsibilities was extracted from the full submitted research protocol. The protocol includes two studies (CHS1 and CHS2). At the time of the study registration CHS1 was partially analyzed whereas CHS2 has not been initiated. See below the full description of the two studies' protocols. To explore the probability of mental illness (MI) onset or psychiatric relapse following infections, we will utilize two databases from the CHS registries from Israel (n=50,000, n=69,594). Participants with a high load of past infections (cohort 1, n=50,000) will be identified and matched in a 1:1 ratio to controls by age and sex. Probability of MI onset across a broad range of psychiatric disorders, including depression, bipolar disorder, anxiety and psychotic disorders will be explored. The probability of psychiatric relapse among individuals with pre-existing mental disorder following infection will be investigated in a cohort of 34,797 individuals with schizophrenia matched randomly to age and sex controls with no diagnosis of schizophrenia (n = 34,797) (cohort 2, total n=69,594, 5). Socio and sociodemographic factors which might serve as vulnerability or resilience factors will be assessed across both cohorts, and will include environmental factors such as socioeconomic status, familial status, healthcare utilization information and demographic factors. In addition, The CHS databases (n=50,000, n=69,594) will be utilized to study outcomes of infections in SMI. From the CHS databases in Israel, outcome of infections will be assessed in the two previously described cohorts. Severe outcomes will be defined as hospital admission \~two weeks after a diagnosis of an infection, among individuals with pre-existing anxiety, depression, bipolar diagnosis (n=50,000), and among patients with schizophrenia (n=69,594), as well as all-cause mortality. The following infections will be considered: Epstein Barr Virus, Cytomegalovirus, Toxoplasma Gondii, COVID-19, and Herpes viruses. Environmental protective and risk factors and their moderating role in the association between infection and outcome will include marital status, number of siblings, and sociodemographic factors. Vulnerability factors such as smoking, obesity, and comorbid physical illness will also be examined. The presence of pre-existing viral infections will be assessed as a potential vulnerability factor.

A Novel Blood Test as a Biomarker in Mental Health

This longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the Royal Columbian Hospital Psychiatric Clinics. The study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. To achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: Depression (DEP) or Psychosis/Schizophrenia (PSY).