Depression Paid Clinical Trials in California

Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) Read Less

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD) Read Less

The primary objective will be to study changes in putamen connectivity and depression severity in depressed teens with meditation training. H1: Putamen node strength will increase in the training group compared to the active controls. H2: This increase in node strength will correlate with practice amount recorded by participants. H3: There will be a significant reduction in self-rated depression symptoms following the training as measured by the Reynolds Adolescent Depression Scale (RADS-2), compared to controls. H4: This reduction will correlate with the increase in putamen node strength. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, active-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen structural node strength) and secondary outcome (depression symptoms measured using Reynolds Adolescent Depression Scale [RADS-2]) in depressed adolescents between the ages of 14 to 18 years old. Read Less

Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of ~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD. Read Less

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Read Less

The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are: Is the Down Dog prenatal yoga app feasible for AA pregnant women? How does mental and physical health change after using the Down Dog app for 12-weeks? What cultural adaptations to the Down Dog app are needed? The study lasts for 12 weeks and participants are asked to: do prenatal yoga with the app for at least 20 min/day, three days/week, from home wear a Garmin Vivosmart 5 watch daily complete four online surveys complete an optional virtual interview This project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes. Read Less

This randomized two-arm intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly active whole-body hyperthermia (active WBH) sessions or 4 bi-weekly sham WBH sessions to adults aged 18 years or older with major depressive disorder (MDD). Read Less

This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF. Read Less

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 657 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth. Read Less

Veterans with comorbid chronic pain and depression are highly prevalent, have poor functional status and low quality of life, are at increased risk of suicide and lack access to effective treatments. To address this problem, the proposed research will examine the feasibility of a novel approach that integrates repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy with the overall goal of maximizing functional improvement in Veterans with chronic pain and depression. This is an important first-step in preparation for a future randomized efficacy trial. The investigators will also include two cognitive control tasks with concurrent electroencephalography to explore as a potential objective indicator of treatment response. This application addresses a critical need within the Veterans Health Administration and is closely aligned with the focus area of developing suicide prevention treatments that influence participation in life roles. Read Less

Despite the prevalence and significant public health concern over depression among adolescents, up to 40% of depressed adolescents do not respond to first-line antidepressants (herein termed treatment non-response, TNR). The goal of this project is to recruit and assess 160 treatment-seeking depressed adolescents and test whether acute stress impacts peripheral levels of inflammation and downstream levels of glutamate in corticolimbic regions previously associated with depression, whether these stress-related biomarkers predict TNR to a 12-week trial of either fluoxetine or escitalopram, and whether these stress-related biomarkers predict 18-month clinical course. Read Less

This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention. Read Less