Coppell

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years who have severe uncontrolled asthma. These children must be on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, double-blind, placebo-controlled study aims to better understand how tezepelumab affects asthma control in this pediatric population. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo for 52 weeks during the double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in phase. After the treatment period, a 12-week follow-up phase occurs without treatment. Eligible participants can then join an optional open-label extension, receiving tezepelumab for an additional 104 weeks followed by another 12-week post-treatment follow-up. Throughout the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. Researchers will measure the annualized rate of severe asthma flare-ups from the start of treatment to week 52. Safety and treatment adherence will also be closely monitored during all study phases, with total participation potentially extending over two years for those in the extension period.

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.

Measuring intracranial pressure (ICP) is crucial for treating serious neurological conditions. Traditional ICP measurement requires an invasive procedure involving drilling into the skull to place a monitor. A new non-invasive device developed by Brain4Care uses a small sensor placed on the head to detect tiny skull movements with each heartbeat, creating a waveform similar to that from invasive monitors. However, more research is needed to understand how this non-invasive device can be used effectively in clinical practice. The study evaluates the Brain4Care non-invasive ICP monitor, which uses piezoelectric sensors to capture skull pulsations corresponding to the ICP waveform. The device analyzes features like the P2/P1 ratio and time to peak of the waveform. This research investigates how the waveform changes when patients undergo standard ICP-lowering treatments during their usual care, including those who have had craniotomies, lumbar punctures, or shunt adjustments. Participants will be adults over 18 receiving neurocritical or neurosurgical care involving ICP management. Researchers will monitor the ICP waveform from enrollment through up to 100 weeks, focusing on changes in the P2/P1 ratio. Throughout the study, clinical assessments and waveform measurements will be collected to better understand the non-invasive monitor's response to ICP-lowering procedures, aiming to improve its clinical utility and safety monitoring over time.

Researchers are evaluating the effectiveness of an online program designed to strengthen romantic relationships and improve individual well-being for couples where one or both partners are in recovery from substance misuse. The program is based on Integrative Behavioral Couple Therapy and has been adapted to address issues related to addiction and recovery. Previous studies showed that the program improved relationship satisfaction, confidence, and reduced conflict, with additional benefits in individual mental health and functioning. The program includes approximately 8 to 10 hours of digital content delivered over 5 to 8 weeks. Couples complete most of the material independently and come together for 2 to 3 key conversations focused on identifying and addressing core relationship problems. The content features videos, interactive feedback, and tailored information addressing recovery-related challenges. Participants also receive up to 100 minutes of coaching calls via Zoom or phone, spread before, during, and after the program. Participants complete online surveys before and after the program, which lasts about 8 weeks, and are compensated for their time. Researchers assess relationship satisfaction and conflict from enrollment until the end of the program or dropout. The study recruits couples from recovery organizations and monitors their progress through questionnaires and coaching sessions, aiming to support relationship and recovery outcomes.

Researchers are evaluating the safety and effectiveness of MANP (modified atrial natriuretic peptide) given by subcutaneous injection to reduce daytime systolic blood pressure in adults with difficult to control or resistant hypertension. This Phase 2 study compares MANP to a placebo in participants who are taking three or more antihypertensive medications with different mechanisms of action. The study focuses on people aged 18 to 80 years who have high blood pressure despite treatment. Participants will receive daily injections of either MANP or a placebo for 42 days. This dose-titration study monitors the response to the treatment over this period. The placebo used is a matched vehicle without the active ingredient. The study aims to observe changes in blood pressure and evaluate potential side effects during and after treatment. During the study, participants will have their blood pressure measured using 24-hour ambulatory blood pressure monitoring to assess changes from baseline. Researchers will also monitor and record any adverse events, serious adverse events, and treatment-emergent adverse events for up to four weeks after the treatment ends, which totals approximately 10 weeks of follow-up. These assessments help determine the safety and efficacy of MANP in this population.