Coppell

Bipolar disorder is a serious, long-lasting mood condition affecting both adults and children. This research focuses on studying the effects and safety of cariprazine, a medication approved for adults, in treating depressive episodes linked to bipolar I disorder in children and adolescents aged 10 to 17. The study aims to better understand how this drug impacts the pediatric population, where treatment options are currently limited. Participants will be randomly assigned to one of two groups one receiving cariprazine at flexible doses adjusted by age and weight, and the other receiving a placebo. The treatment lasts six weeks, with dose adjustments at week 3 depending on response. Following treatment, there is a four-week safety follow-up period. Weekly visits at clinics or hospitals will support monitoring and treatment. During the study, participants will undergo medical assessments, blood tests, questionnaires, and side effect checks to evaluate the drugs impact. Researchers will track changes in mood symptoms using scales like the Childrens Depression Rating Scale and monitor safety through vital signs, lab tests, and movement assessments. The total study participation spans around 10 weeks, including treatment and follow-up.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

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.

Measuring the pressure inside the skull, known as intracranial pressure ICP, is important for treating serious neurological conditions. Currently, measuring ICP requires an invasive procedure where a monitor is placed inside the skull. Researchers are evaluating a new non-invasive device from Brain4Care that uses a tiny pin placed on the head to detect small skull movements with each heartbeat, producing a waveform similar to invasive ICP measurements. This study aims to understand how this non-invasive ICP monitor waveform changes during standard treatments that lower ICP. The study involves adult patients over 18 who are undergoing brain surgery requiring hyperosmolar agents, those receiving lumbar punctures in neuro-oncology or neurosurgery clinics, or patients with ventriculo-peritoneal shunts needing adjustments. The non-invasive Brain4Care device will be used to monitor ICP waveforms as patients receive their usual care. The device measures skull pulsations to generate a waveform analyzed by factors like the P2P1 ratio and time to peak, which relate to intracranial pressure dynamics. Participants will be observed during their routine clinical care with the non-invasive device monitoring their intracranial pressure waveforms. Researchers will track changes in the P2P1 ratio from enrollment through completion, which may last up to about 100 weeks. The study includes assessments during various ICP-lowering procedures, and participants must be able to consent for themselves. No experimental treatments will be given, and the focus is on gathering data to better understand the devices clinical usefulness.

This research aims to evaluate an online relationship program designed for couples where one or both partners are in recovery from substance misuse. The study focuses on strengthening romantic relationships and improving individual well-being by addressing common issues like relationship conflict and distress that can interfere with substance use disorder SUD recovery. The program is based on Integrative Behavioral Couple Therapy IBCT, adapted for digital delivery and tailored specifically to the challenges faced by couples in recovery. Couples in this study will participate in approximately 8 to 10 hours of online content delivered over 5 to 8 weeks. The program includes sections called Observe, Understand, and Respond, which guide partners through identifying relationship problems, understanding core issues, and developing strategies to improve communication and reduce stress. The content features videos, audio, graphics, interactive feedback, and examples of diverse couples. Couples also receive up to five 20-minute coaching calls conducted via phone or Zoom to support their progress throughout the program. Participants will complete online surveys before starting and after finishing the program to assess changes in relationship satisfaction, conflict, emotional trust, and recovery-related factors. Researchers will monitor progress during the approximately 8-week intervention period. The study provides 200 per couple for completing surveys. Throughout participation, couples will have access to digital content and scheduled coaching, aiming to support both relationship and individual recovery. The total involvement includes program completion and follow-up assessments.

This research aims to evaluate the safety and tolerability of lumateperone in pediatric patients diagnosed with schizophrenia, bipolar disorder, or autism spectrum disorder. It is a global, multicenter, open-label study lasting 26 weeks. The study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. Participants will receive lumateperone capsules or orally disintegrating tablets once daily, with doses ranging from 5 mg to 42 mg, adjusted by age and condition. The study begins with up to a 2-week screening period to confirm eligibility, followed by a 26-week open-label treatment period where all patients receive lumateperone. After the treatment period, there is a 2-week safety follow-up visit to monitor participants after their last dose. During the study, participants will be monitored regularly through clinic visits, where safety and tolerability will be assessed. Researchers will track the incidence of common adverse events throughout the 6-month treatment and follow-up period. Participants must maintain outpatient status during the trial. The total participation duration spans approximately 28 weeks, including screening, treatment, and safety follow-up.

Researchers are studying a treatment called MANP modified atrial natriuretic peptide for people with difficult to control or resistant hypertension. This Phase 2 study compares the safety and effects of daily MANP injections to a placebo in reducing daytime systolic blood pressure over 42 days. Participants are adults aged 18 to 80 who are already taking three or more blood pressure medications. Participants will be randomly assigned to receive either MANP or a placebo injection once daily for 42 days. The MANP is given as a subcutaneous injection. The study is double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo until the study ends. A subset of participants with slightly reduced kidney function may also be included, but not exceeding 10% of total enrollment. During the study, participants will have their blood pressure monitored closely using 24-hour ambulatory blood pressure devices and clinic measurements. Safety will be assessed through reports of side effects and serious adverse events up to 4 weeks after treatment ends. Blood samples will be taken for pharmacokinetic and antibody testing. The total study duration includes about 42 days of treatment plus 4 weeks of safety follow-up.