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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying how biological factors might influence the link between depression and the development of Alzheimer's disease (AD). The goal is to understand whether treating depression affects key Alzheimer's disease biomarkers. This is a Phase 4 study comparing an FDA-approved antidepressant, escitalopram, with a placebo to see if reducing depressive symptoms can normalize cerebrospinal fluid biomarkers and peripheral inflammatory markers associated with AD. Participants will receive either escitalopram or a placebo daily. The initial dose for escitalopram is 10 mg for the first two weeks, then increased to 20 mg if tolerated, with the option to reduce back to 10 mg if needed. The placebo group will receive a daily dose designed to mimic the escitalopram regimen. This setup allows researchers to compare the effects of the antidepressant with placebo on biological markers related to Alzheimer's disease. During the study, participants will be closely monitored with brain MRI scans, urine drug screens, blood tests, lumbar punctures, and genotyping. Researchers will measure changes in cerebrospinal fluid biomarkers, vascular dysfunction markers, and depression severity using the Montgomery-Asberg Depression Rating Scale at baseline and after eight weeks. Safety and cognitive function will also be assessed throughout the study. Participants must be cognitively unimpaired older adults aged 60 and above, and the study involves regular health and neurological examinations to track progress and ensure safety.
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Healthy Volunteer
Researchers are evaluating the effects of hip bump manipulation (HBM) on healthy adults aged 18 to 45 years. The study aims to objectively measure whether HBM improves hip internal rotation passive range of motion, strengthens the hip external rotators, reduces compensatory hip flexion during active movement, and enhances bipodal landing mechanics. Although clinicians commonly use this technique, its effectiveness has not yet been confirmed by research. The manipulation is a high velocity low amplitude thrust applied to the greater trochanter, intended to stretch the external rotator muscles and potentially correct femoral head positioning within the hip socket. Participants will receive either the hip bump manipulation or a sham treatment where no real manipulation is applied, specifically an iliac crest sham manipulation. The HBM involves a quick thrust directed posteriorly to the greater trochanter. The study compares these two groups to assess the intended clinical effects of the manipulation. During a single session lasting about 20 minutes, researchers will measure hip external rotation strength, hip internal rotation range of motion, hip muscle activation using EMG, and bipodal landing mechanics before and after the intervention. These assessments will help determine the immediate impact of the manipulation. The study focuses on healthy adults and monitors functional movements and muscle responses associated with hip function.
Actively Recruiting
Researchers are evaluating whether an integrated harm reduction intervention (IHRI) can improve the use of harm reduction services among Black and Latinx people who use drugs. This study focuses on individuals misusing opioids and possibly other substances, aiming to compare IHRI with usual harm reduction services to see which better supports participants. The study addresses drug use, substance abuse, and mental illness within these communities. The intervention being studied is an 8-week program based on the eight principles of harm reduction. It includes weekly educational lessons and provides informed referrals to social service organizations. Participants receive this integrated program in comparison to standard harm reduction services, allowing researchers to assess differences in service utilization. Participants will be monitored for their attendance at harm reduction sessions up to 8 weeks, specifically tracking those who attend at least one session after the introductory session and those who attend three or more sessions in total. The study includes assessments through interviews confirming substance misuse based on DSM-5 criteria and collects data on service engagement. Eligibility and safety are carefully evaluated throughout the study period.
Actively Recruiting
Researchers are evaluating lumateperone in a multicenter, randomized, double-blind, placebo-controlled phase 3 study for children aged 5 to 17 years with irritability associated with Autism Spectrum Disorder (ASD). The diagnosis of ASD is based on DSM-5-TR criteria and confirmed using the K-SADS-PL assessment. The study focuses on measuring irritability symptoms in this pediatric population. The study has three phases: a screening period up to 14 days to check eligibility, a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose. Treatments are taken orally once daily during the treatment phase. Participants and their caregivers will attend clinic visits for assessments including the Aberrant Behavior Checklist - Irritability subscale measured at week 6 to evaluate treatment effects. Safety monitoring occurs during treatment and follow-up. Caregivers must provide consent, and children may provide assent when appropriate. The total participation duration includes screening, 6 weeks of treatment, and one week of safety follow-up.
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Healthy Volunteer
Researchers are evaluating how cannabis use affects brain function in adolescents with depression. This study includes participants aged 14 to 20 years and aims to understand the neural and psychiatric consequences of cannabis on this population. The study captures a wide range of cannabis use and depression severity, including subthreshold depression and major depressive disorder, to reflect diverse experiences among adolescents. Participants will undergo functional MRI (fMRI) scans twice: once at the start of the study and again one year later. During each scan, they will complete tasks designed to assess different aspects of brain reward systems. After the second scan, participants will be followed clinically for an additional year to monitor changes and outcomes. Throughout the study, researchers will measure depression severity using the Beck Depression Inventory, anhedonia severity with the Temporal Experience of Pleasure Scale, and cannabis use patterns via a detailed inventory. The total observation period extends up to three years, allowing for long-term assessment of mental health and cannabis impact. Participants will be monitored for safety, and clinical evaluations will be conducted regularly to track their progress.
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Researchers are studying the effects of transcranial direct current stimulation (tDCS) on improving face emotion recognition (FER) in individuals with schizophrenia and schizoaffective disorder. tDCS is a non-invasive brain stimulation technique that uses low electrical currents over the scalp to influence brain function. The study focuses on the middle temporal motion-sensitive brain area (MT+) to address motion processing deficits that contribute to social cognition difficulties in schizophrenia. The research uses brain imaging methods including functional MRI (fMRI) and EEG to measure brain activity while participants view moving dot patterns and dynamic faces. The study includes a randomized, parallel group comparison between personalized, MRI-guided cathodal high-definition tDCS targeting MT+ and a sham stimulation designed to mimic the sensation without delivering current. Participants with schizophrenia will undergo baseline assessments and then receive two sessions of either active or sham tDCS during EEG and fMRI visits spaced at least one week apart. Healthy controls will undergo baseline evaluations only. Both sessions involve up to 40 minutes of stimulation while brain activity and behavior are measured. Participants will complete assessments including brain imaging during stimulation, behavioral tests of motion discrimination and FER, and questionnaires measuring social cognition. Researchers will monitor brain region activation and dynamic brain state changes during the interventions. The study aims to correlate brain activity changes with behavioral improvements and compare effects between active and sham stimulation. The total participation involves up to four visits including baseline, EEG, and fMRI sessions, with safety and brain function closely monitored throughout.
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Healthy Volunteer
Researchers are evaluating whether daily polyvagal breathing exercises can reduce stress and anxiety in healthy physical therapy students aged 18 to 45 at Dominican University New York. The study compares students who practice these breathing exercises to a control group that does not receive any intervention. The goal is to see if stimulating the polyvagal system through these exercises lowers stress and anxiety levels in this population. Participants in the experimental group will practice three types of breathing exercises: square breathing, modified Qigong breathing, and three-step breathing, over a 30-day period. The control group will not perform any breathing exercises but will watch a video about stress and general stress relief tips. Both groups will use a laptop to complete surveys and questionnaires, and the experimental group will receive video instructions for the breathing exercises. During the study, participants will undergo three data collection sessions on days one, fifteen, and thirty. Brain activity will be measured using a safe, non-invasive DSI-7 EEG headset while participants sit quietly and during timed quizzes designed to induce mild stress. EEG recordings and questionnaires will assess stress and anxiety levels. Participants may withdraw at any time if they feel uncomfortable. The study is supervised by experienced researchers following safety protocols.
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Researchers are evaluating whether applying near infrared energy to the forehead can change blood flow in the brains of adults with Major Depressive Disorder (MDD). This multi-center study involves about 60 participants diagnosed with MDD, aiming to assess changes in cerebral blood flow and depression symptoms using MRI scans and clinical rating scales. Near infrared energy used in the study is a type of light not visible to the human eye. Participants will be randomly assigned to receive either real or sham transcranial photobiomodulation (tPBM) treatments. The active device delivers continuous near-infrared radiation to the forehead, while the sham device emits no radiation. The treatment consists of 16 sessions, and MRI scans are conducted during the tPBM both before and after this treatment course. Throughout the study, participants will undergo multiple assessments including MRI scans and depression rating scales to measure changes in brain blood flow and symptom severity. Researchers will monitor safety and treatment adherence. Key outcomes include the percent change in cerebral blood flow and changes in depression severity scores measured at specified visits up to 10 weeks. The study includes adults aged 18 to 65 years with stable treatment for depression prior to participation.