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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

This research focuses on pediatric participants aged 6 to 17 years with obesity or overweight conditions. Its aim is to establish a framework to evaluate the safety and effectiveness of drug treatments for managing chronic weight issues in this population. The study is part of a Phase 3 Master Protocol that includes multiple interventions and will report results when all intervention-specific arms finish. Participants may receive either Orforglipron, a drug given orally, or a placebo, also taken by mouth. Different intervention-specific arms may begin independently as new treatments become available for testing. The study sets clear entry criteria for newly enrolled participants across these intervention arms. During the study, researchers will monitor participants from baseline up to 72 weeks, focusing on the number of participants allocated to each intervention arm. They will also track safety and treatment effectiveness. Participation involves regular assessments of weight, health status, and any side effects, ensuring a thorough evaluation of the chronic weight management interventions over time.

Age: 6Years - 17YearsAll GendersPhase 3
50 locations
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Actively Recruiting

Researchers are evaluating the effects of orforglipron, an oral medication taken once daily, compared to a placebo in adolescents with obesity or those who are overweight with related health issues. This Phase 3 study aims to assess the medicine's safety, how it is processed in the body, and how well it works over a period lasting about 18 months. Participants include adolescents aged 12 to 17 years who have struggled to lose weight despite previous diet and exercise programs. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken by mouth once daily. The study will monitor changes in body mass index (BMI) from the start of the trial to week 72. Those in the study must meet specific criteria related to their BMI percentiles and presence of weight-related conditions such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, or certain liver diseases. During the study, participants will be regularly evaluated through medical assessments that include measuring BMI and monitoring overall health and safety. Researchers will track how the body responds to orforglipron and observe any side effects. The study's total length of participation is approximately 18 months, allowing close follow-up to understand long-term effects and treatment outcomes.

Age: 12Years - 17YearsAll GendersPhase 3
37 locations
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Actively Recruiting

Researchers are evaluating how well vortioxetine tablets at doses of 10 mg/day or 20 mg/day work compared to placebo tablets for treating depression symptoms in Japanese teenagers aged 12 to 17 years who have been diagnosed with Major Depressive Disorder (MDD). This phase 3 clinical trial aims to assess the drug's effectiveness, safety, and how the body processes the medication in this pediatric population. Participants will be randomly assigned to receive either vortioxetine or a placebo once daily for 14 weeks. The study includes an initial screening period of up to 15 days to determine eligibility, followed by the 14-week treatment phase. After completing treatment, there is a 4-week period dedicated to monitoring any side effects. Throughout the study, participants will visit the clinic 13 times for assessments and medication administration. During the study, participants will undergo evaluations including the Children Depression Rating Scale Revised version (CDRS-R) to measure changes in depression symptoms from baseline to week 14. Other assessments include safety monitoring and pharmacokinetics. Researchers will also collect information on side effects during and after treatment. The total time commitment for participants is about 20 weeks, including screening, treatment, and follow-up periods.

Age: 12Years - 17YearsAll GendersPhase 3
30 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This Phase 3 study focuses on adolescents who meet diagnostic criteria for schizophrenia and experience symptoms of psychosis. The study aims to better understand how KarXT may impact symptoms as measured by a standard schizophrenia rating scale. Participants will receive either KarXT or a matching placebo at specified doses on specific days. The study is randomized, double-blind, and placebo-controlled, meaning neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, researchers will assess changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS) after 5 weeks of treatment. Participants will be monitored for safety and symptom changes throughout the study period. The goal is to gather detailed information about KarXT's impact on schizophrenia symptoms in this adolescent population.

Age: 13Years - 17YearsAll GendersPhase 3
43 locations
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Actively Recruiting

Researchers are assessing the long-term safety and tolerability of two treatments, KarXT and KarX-EC, for adolescents with schizophrenia and children and adolescents with irritability related to autism spectrum disorder. This Phase 3, multicenter, open-label study includes participants aged 5 to 17 years and aims to monitor how these treatments are tolerated over time in these specific populations. Participants receive KarXT or a combination of KarXT and KarX-EC at specified doses on designated days. The study includes adolescents aged 13 to 17 years with schizophrenia and children and adolescents aged 5 to 17 years with autism-related irritability. Treatment is administered openly, meaning both researchers and participants know the treatment being given. Throughout the study, researchers will evaluate participants for any treatment-emergent adverse events, adverse events of special interest, and serious adverse events for up to 54 weeks. Safety assessments include monitoring physical examinations, vital signs, and ECGs. Participants must have completed earlier related studies without safety concerns to join, and their health will be closely monitored during the study to ensure safety and tolerability.

Age: 5Years - 17YearsAll GendersPhase 3
59 locations
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