Leszno

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the effects of SPT-300 (GlyphAllo), a prodrug of allopregnanolone, in adults aged 18 to 65 years who have major depressive disorder (MDD), with or without anxious distress. This Phase 2 study is randomized, double-blind, placebo-controlled, and aims to assess the efficacy, safety, and tolerability of SPT-300 as a monotherapy treatment for MDD. Participants will receive either SPT-300 or a placebo and will be monitored over a 42-day treatment period. The study compares the impact of SPT-300 to placebo on depressive symptoms and any side effects experienced. The intervention is given as a drug treatment, and participants are randomly assigned to one of the two groups. Throughout the study, researchers will measure changes in depression severity using the Hamilton Depression Rating Scale-17 (HAM-D-17) total score from the start of the treatment to day 42. Participants will be assessed for safety and tolerability, and their adherence to treatment will be monitored. The study focuses on the depressive episode lasting between 4 weeks and 18 months, with careful screening to ensure participant eligibility and safety.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Researchers are evaluating ITI-1284 as an additional treatment for adults with Generalized Anxiety Disorder (GAD) who have not responded well to their current GAD treatment. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet specific diagnostic criteria for moderate or severe GAD and have shown inadequate improvement from at least one approved GAD medication. The study consists of three periods: a screening phase lasting up to 3 weeks to confirm eligibility and allow for withdrawal of prohibited medications; a 6-week double-blind treatment period where participants are randomly assigned to receive ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all administered once daily as sublingual tablets; and a 1-week safety follow-up period to monitor participants after treatment ends. During the study, participants will be closely monitored with assessments including the Hamilton Anxiety Rating Scale at week 6 to measure anxiety levels. Other evaluations include clinical interviews and safety checks to ensure participant well-being. The study tracks treatment adherence and collects data on the safety and tolerability of ITI-1284 throughout the treatment and follow-up periods.

Researchers are evaluating ITI-1284 as a monotherapy treatment for adults diagnosed with moderate to severe Generalized Anxiety Disorder (GAD) who have not responded adequately to previous GAD treatments. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet the DSM-5-TR criteria for GAD and have a significant level of anxiety as measured by clinical scales at screening and baseline. The study includes three periods: a screening period of up to 2 weeks to evaluate eligibility and allow washout from prohibited medications; a 6-week double-blind treatment period where about 570 participants are randomly assigned in equal groups to receive either ITI-1284 10 mg, ITI-1284 20 mg, or a matching placebo once daily via sublingual tablets; and a 1-week safety follow-up period after the last dose of the study drug. The treatments are administered once daily under blinded conditions. Participants will be involved in multiple assessments throughout the study, including evaluations of anxiety symptoms using the Hamilton Anxiety Rating Scale (HAM-A) at Week 6. Eligibility and safety are confirmed through structured interviews and clinical rating scales. Researchers will monitor treatment response, adverse events, and overall safety during the treatment and follow-up periods. The total participation duration includes screening, treatment, and safety follow-up visits.