Stone Mountain

Researchers are evaluating zelquistinel, a drug aimed at reducing symptoms of major depressive disorder in adults aged 18 to 64 years. This Phase 2 clinical trial compares the effects and safety of zelquistinel to a placebo in participants diagnosed with major depressive disorder. The study will focus on changes in depression severity and monitor any medical issues that arise during treatment. Participants will take one tablet of either zelquistinel or placebo once a week for six weeks. The trial includes a screening period of up to 28 days, followed by a 42-day treatment phase, and then a four-week follow-up period. During treatment, participants will visit the clinic weekly to receive their dose and have their depression symptoms assessed using the Hamilton Depression Rating Scale-17. Throughout the study, participants will have their depression severity regularly evaluated, along with monitoring for adverse events or side effects. The study lasts up to 98 days, including screening, treatment, and follow-up. Researchers will measure changes in depression scores from the beginning to the end of treatment and monitor overall safety during this time.

Researchers are evaluating the effects of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode, also known as bipolar depression. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of azetukalner in this population. Participants must have had their first major depressive episode before age 50 and meet specific diagnostic criteria confirmed by clinical interview. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo orally once daily with food, preferably with the evening meal, for six weeks. The study has two groups one receiving the experimental drug and one receiving a placebo, both taken over the same period. The study is designed to keep participants and researchers unaware of the group assignments to ensure unbiased results. Throughout the trial, participants will be evaluated using various measures, including changes in depression severity assessed by the Montgomery-sberg Depression Rating Scale MADRS at baseline and at week 6, along with other scales at different time points. Safety and response will be monitored regularly during the six-week treatment period. The entire participation period is focused on this treatment phase, with assessments conducted to measure changes in symptoms and overall condition.

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 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 studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

Researchers are evaluating the use of a cellular, acellular, matrix-like product called Amnio-Maxx4 Dual Layer Amnion Patch alongside the Standard of Care SOC compared to SOC alone for closing nonhealing diabetic foot ulcers DFUs. This Phase 4 randomized controlled trial focuses on adult patients with chronic DFUs to better understand how Amnio-Maxx may affect healing rates. Participants will receive either the Standard of Care, which includes cleansing, debridement, wound documentation, and off-loading, or the Standard of Care plus the application of the Amnio-Maxx Dual Layer Amnion Patch. The study uses random assignment without masking. Treatments are applied during study visits, and the ulcer is carefully monitored for closure and healing progress. During the 12-week trial, participants will undergo assessments including ulcer measurements to evaluate complete closure and percentage area reduction. Pain related to the ulcer will be tracked using the Numeric Pain Rating Scale. Researchers will also monitor adverse events throughout the study. Participants must follow treatment protocols and attend regular visits to support accurate evaluation of outcomes related to healing diabetic foot ulcers.

Researchers are evaluating a mental health and resilience program designed specifically for Ethiopian and Eritrean youth aged 18 to 29 living in the Atlanta metropolitan area. This study addresses high rates of depression, anxiety, and post-traumatic stress disorder among these communities by testing a culturally tailored group intervention. The goal is to assess the acceptability, feasibility, and safety of this program before conducting a larger trial to support mental wellness in a community setting. The intervention, called Weyera, consists of eight weekly group sessions lasting about two hours each. Led by trained community health workers, these sessions offer psychoeducation, coping skills training, and open discussions on topics such as mental health, stress, identity, family relationships, trauma, and accessing mental health services. Participants are randomly assigned either to start the intervention immediately or to a wait-list control group that begins the program after four months. During the study, participants complete surveys before, during, and after the intervention at 2, 4, 6, and 8 months to measure satisfaction, recruitment and retention rates, mental health symptoms, social support, ethnic identity, resilience, and use of mental health services. Some participants will also take part in interviews. The study monitors safety throughout the six-month follow-up period to gather comprehensive information on the interventions impact and feasibility.