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Found 8 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying how depression might influence the risk of developing Alzheimers disease AD by examining biological factors involved in both conditions. The study focuses on adults aged 60 and older with major depressive disorder and aims to understand whether treating depression affects Alzheimers-related biomarkers in the body. This research will use an FDA-approved antidepressant and compares its effects to a placebo in a controlled trial. Participants receive either escitalopram, a selective serotonin reuptake inhibitor SSRI, or a matching placebo. The medication starts at 10 mg daily for two weeks and may increase to 20 mg as tolerated, with the option to reduce the dose if needed. The treatment period lasts for eight weeks, during which changes in cerebrospinal fluid biomarkers related to Alzheimers disease and vascular dysfunction will be tracked alongside depression symptom scores. Throughout the study, participants will undergo physical and neurological exams, brain MRI scans, lumbar punctures, blood and urine tests, and cognitive assessments. Researchers will monitor changes in Alzheimers biomarkers and depression severity using specific scales at the start and end of the treatment period. The study includes safety monitoring and requires participants to be medically stable and cognitively unimpaired at the start. The total participation time covers the screening and an eight-week treatment phase.

Age: 60Years +All GendersPhase 4
2 locations
S

Actively Recruiting

Healthy Volunteer

Researchers are studying the effects of hip bump manipulation HBM on healthy adults aged 18 to 45 years. The study aims to determine if HBM can improve hip internal rotation, increase the strength of hip external rotator muscles, reduce compensatory movements during hip flexion, and enhance landing mechanics. Although clinicians often use this high velocity low amplitude thrust technique, its benefits have not yet been proven through research. Participants will be randomly assigned to one of two groups one receiving the hip bump manipulation targeting the greater trochanter, and the other receiving a sham manipulation at the iliac crest. Both procedures are performed in a single session lasting about 20 minutes. This single-blinded trial compares the clinical outcomes between the active and sham groups. During the study visit, participants will undergo assessments before and after the intervention, including measures of hip external rotation strength, hip internal rotation range of motion, muscle activation via EMG, and bipodal landing mechanics. Additional measures include hip deviation with assisted hip flexion and external rotation range of motion. The entire evaluation occurs within one session, and the study concludes after these assessments.

Age: 18Years - 45YearsAll GendersPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are evaluating an integrated harm reduction intervention IHRI compared to usual harm reduction services for Black and Latinx people who use drugs PWUD. The study aims to improve the use of harm reduction services among this highly marginalized population. The trial is interventional and focuses on addressing substance abuse and related mental health issues through culturally tailored support. The integrated harm reduction intervention lasts 8 weeks and includes weekly education lessons during the first 4 weeks led by an IHRI care coordinator. During the following 4 weeks, participants receive personalized identification of social vulnerabilities to connect them with relevant social service organizations. Both the IHRI group and the usual harm reduction services group interact with mobile vans providing information on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. Participants will be involved for up to 8 weeks, with researchers monitoring their attendance at harm reduction sessions and changes in substance use patterns, overdose risk, and quality of life. Key measurements include the percentage attending harm reduction sessions, changes in days of opioid or stimulant use, overdose risk assessment scores, and quality of life scores. The study includes random assignment to groups and does not involve masking or blinding.

Age: 18Years +All GendersPhase Not Applicable
3 locations
S

Actively Recruiting

Researchers are evaluating lumateperone for treating irritability in children and adolescents aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD. This randomized, double-blind, placebo-controlled study focuses on pediatric patients with confirmed ASD diagnosis and irritability symptoms as measured by specific behavioral scales. Participants will be randomly assigned to receive either a high dose or low dose of lumateperone, or a placebo, taken orally once daily during a 6-week double-blind treatment period. The study includes a screening period up to 14 days to confirm eligibility, followed by a 1-week safety follow-up visit after the last dose. During the trial, participants will undergo assessments including behavior checklists for irritability and clinical global impression scales at week 6. Safety and tolerability will be monitored throughout the study. The total participation time includes screening, 6 weeks of treatment, and a safety follow-up week, with regular visits to the clinic for evaluations.

Age: 5Years - 17YearsAll GendersPhase 3
40 locations
S

Actively Recruiting

Healthy Volunteer

Researchers are investigating how cannabis use affects brain function in adolescents with depression. The study aims to understand the neural and psychiatric consequences of cannabis use, focusing on a wide range of depression severity and cannabis use patterns among participants aged 14 to 20 years. This research is sponsored by the University of Miami and includes both cannabis users and non-users with depressive symptoms or diagnoses. Participants will undergo neuroimaging using functional MRI fMRI at the start of the study and again at a one-year follow-up. Each fMRI session lasts about one hour and involves tasks that evaluate different aspects of reward circuitry activity in the brain. Following the imaging sessions, participants will be clinically followed for an additional year, with assessments continuing for up to three years total. During the study, participants will complete various evaluations including standardized questionnaires to measure depression severity, anhedonia loss of pleasure, and cannabis use frequency and quantity. Urine tests will be used to analyze cannabinoid metabolites. Researchers will monitor changes over time using tools such as the Beck Depression Inventory and the Montgomery-sberg Depression Rating Scale. Participants may also undergo clinical interviews and provide self-reports about symptoms and substance use. The total participation time may extend up to three years with periodic assessments.

Age: 14Years - 20YearsAll GendersPhase Not Applicable
2 locations
B

Actively Recruiting

Researchers are studying whether transcranial direct current stimulation tDCS, a non-invasive brain stimulation technique, can improve face emotion recognition in people with schizophrenia. The study focuses on applying tDCS over the brains motion processing area area MT to address difficulties in detecting facial motion, which contribute to social cognition challenges in schizophrenia. Brain activity will be measured using fMRI and EEG while participants view moving and dynamic face stimuli, comparing effects of active versus sham stimulation. Participants include 120 individuals with schizophrenia and 30 healthy controls. Those with schizophrenia will be randomly assigned to receive either active personalized, MR-guided cathodal HD-tDCS targeting area MT or sham stimulation that mimics the sensation without current flow. Each schizophrenia participant will undergo two sessions involving event-related potentials ERP and fMRI with up to 40 minutes of stimulation per session, spaced at least one week apart. Healthy controls will be assessed only at baseline. Participants will complete baseline assessments before randomization and then receive their assigned tDCS intervention during ERP and fMRI visits. Researchers will measure brain region activation related to motion and face emotion recognition, behavioral scores on motion discrimination, face emotion accuracy, and understanding mental states. The study includes comprehensive monitoring of brain responses and behavioral outcomes to evaluate the impact of tDCS over the study period ending in 2030.

Age: 18Years - 55YearsAll GendersPhase Not Applicable
1 location
D

Actively Recruiting

Healthy Volunteer

Researchers are evaluating whether specific daily polyvagal breathing exercises can reduce stress and anxiety in healthy physical therapy students aged 18 to 45. The study compares students who practice these exercises with those who do not, aiming to see if stimulating the polyvagal system through breathing can improve stress levels. This randomized controlled trial is conducted under the supervision of experienced researchers to ensure participant safety. Participants are divided into two groups one group receives a home exercise program of polyvagal breathing exercises, including square breathing, modified Qigong breathing, and three-step breathing, to be practiced daily for at least five minutes over 30 days. The control group watches a video about stress management but does not perform any breathing exercises. Brain activity is recorded using a DSI-7 EEG headset at multiple time points during the 30-day period, including baseline and during timed quizzes designed to induce mild stress. Throughout the study, participants complete questionnaires and surveys via computer, and all instructions are provided digitally to ensure consistency. Data collections occur on days one, fifteen, and thirty, with multiple EEG recordings each day to measure stress and anxiety levels. Participants may withdraw at any time if they feel uncomfortable. The primary outcomes measured are stress and anxiety levels, supported by secondary assessments using standardized scales.

Age: 18Years - 45YearsAll GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are studying if applying near infrared energy to the forehead can change blood flow in the brains of people with Major Depressive Disorder MDD. Near infrared energy is similar to light but invisible to the eye. This multi-center study involves about 60 adults with MDD undergoing MRI scans during transcranial photobiomodulation tPBM before and after treatment. Participants are randomly assigned to receive either active tPBM delivering near-infrared radiation at a dose of 291.7 mWcm2 for 333 seconds or a sham treatment with no radiation, over 16 sessions. All participants receive tPBM at the first and last visits. The treatment course spans multiple visits, with the active or sham treatment given from visit 2 to 18. During the study, participants undergo brain imaging and depression rating assessments at baseline and at various visits up to week 10. Researchers measure changes in cerebral blood flow and depression severity using the Montgomery-Asberg Depression Rating Scale. Safety and adherence are monitored throughout, with the study lasting about 10 weeks per participant.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
3 locations