Bello

Researchers are evaluating the efficacy and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how KarXT impacts symptoms of schizophrenia, a serious mental health condition characterized by psychosis and other challenges. The study is sponsored by Bristol-Myers Squibb and focuses on adolescents experiencing active symptoms and meeting diagnostic criteria. Participants are randomly assigned to receive either KarXT or a matching placebo at specified doses on scheduled days. The study uses a parallel design with two groups one receiving the experimental drug KarXT and the other receiving placebo. Treatment and observation last through the study period, with key assessments taking place up to week 5. Participants will undergo evaluations including symptom severity scales such as the Positive and Negative Syndrome Scale PANSS, Clinical Global Impression scales, and the Childrens Global Assessment Scale CGAS. Researchers monitor changes from baseline in these measures to understand the impact of KarXT. Safety and symptom assessments occur throughout the trial, which runs until December 2029, allowing for careful monitoring of participant health and treatment effects.

Researchers are evaluating the efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17 years. This international, multicenter study is designed as a randomized, double-blind, placebo-controlled trial to understand how cariprazine affects symptoms of schizophrenia in this younger population. Participants will be randomly assigned to receive either cariprazine capsules at doses of 1.5 mg or 4.5 mg once daily, or matching placebo capsules once daily. The treatment phase lasts for six weeks, during which participants take the assigned capsules orally every day. During the study, participants will be monitored regularly to assess changes in their schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also evaluate safety and tolerability throughout the trial. The main measurement is the change in PANSS total score from the start to the end of the six-week period. The study is designed to last until December 2026.

Researchers are evaluating lumateperone for treating bipolar depression in children and teens aged 10 to 17 years who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the effects of lumateperone compared to placebo in this pediatric population. Participants will be randomly assigned to receive either lumateperone or a matching placebo once daily for 6 weeks. The dosage for lumateperone is 42 mg for patients aged 13 to 17 years and 21 mg for those aged 10 to 12 years. The study includes three phases up to 2 weeks of screening to confirm eligibility, 6 weeks of double-blind treatment, and a 1-week safety follow-up visit after the last dose. During the study, participants will undergo assessments including the Childrens Depression Rating Scale-Revised CDRS-R at week 6 to measure depressive symptoms. Safety will be monitored throughout, with a follow-up visit approximately one week after treatment ends. The total participation duration covers screening, treatment, and safety follow-up, ensuring comprehensive evaluation of both efficacy and safety in this age group.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.

This research aims to compare changes in body mass index BMI Z-score in children and adolescents with schizophrenia or bipolar I disorder who are treated with either a combination of olanzapine and samidorphan OLZSAM or olanzapine alone. The study focuses on evaluating weight gain differences between these treatments over time. The trial is a Phase 3, randomized, double-blind study sponsored by Alkermes, Inc., involving pediatric patients aged 10 to 17 years. Participants will be randomly assigned to receive either the fixed dose combination OLZSAM or olanzapine alone. The olanzapine starting dose will be 2.5 mgday or 5 mgday based on the Investigators decision, with a maximum dose of 20 mgday. Samidorphan will be given at a starting dose of 5 or 10 mg. The study duration is 52 weeks, during which participants will be monitored for changes in BMI Z-score and other health measures. During the study, participants will undergo evaluations including BMI measurements at baseline and week 12, waist circumference, and psychiatric assessments using scales like PANSS, YMRS, and CDRS-R. Researchers will also monitor adverse events and track treatment discontinuation over 52 weeks. The main outcome is the change in BMI Z-score at week 12, with additional assessments of symptom changes and safety throughout the study period.