Stone Mountain

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode. The study focuses on participants aged 18 to 74 years who have bipolar depression, aiming to better understand treatment effects in this population. Participants will be randomly assigned to receive either azetukalner at a dose of 20 mg or a placebo, both taken orally once daily with food, preferably with the evening meal. The treatment period lasts for 6 weeks, during which participants will be monitored closely. During the study, participants will undergo assessments including evaluation of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Week 6. Researchers will monitor safety and treatment effects throughout the study. Total participation time covers the 6-week treatment period with ongoing monitoring of symptom changes and safety.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

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.

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.

Researchers are evaluating the effects of a cellular, acellular, matrix-like product called Amnio-Maxx Dual Layer Amnion Patch compared to the standard care alone on healing chronic diabetic foot ulcers (DFUs). This Phase 4 study focuses on patients with nonhealing DFUs, aiming to assess how well the Amnio-Maxx patch helps close these ulcers and reduce their size over 12 weeks. Participants will receive either the Amnio-Maxx patch plus standard care or standard care alone. Standard care includes cleansing, debridement, wound documentation, and off-loading the affected foot. The study involves a screening period followed by randomization to one of the treatment groups, with treatments applied during visits. The index ulcer must be offloaded and have a clean base before treatment. During the study, participants' ulcers will be monitored for complete closure and percentage area reduction at 12 weeks. Researchers will conduct wound assessments, document healing progress, and ensure adherence to offloading. Safety and effectiveness will be tracked throughout, with participants required to follow protocol guidelines and attend scheduled visits during the study period.

Researchers are evaluating a group-level mental health intervention called Weyera designed for Ethiopian and Eritrean youth aged 18 to 29 living in the Atlanta Metropolitan area. This intervention aims to improve mental health and resilience by offering culturally relevant support focused on psychoeducation, coping skills, and open group discussions. The study seeks to find out if this approach is acceptable, feasible, and safe for this community before conducting a larger trial. Participants will be randomly assigned to either an immediate intervention group or a waitlist control group. The intervention involves attending eight weekly group sessions lasting about two hours each, led by trained community health workers. Each session covers topics such as mental health basics, stress, identity, family relationships, trauma, and navigating mental health services, alongside practicing coping strategies like mindfulness. Throughout the study, participants will complete surveys at baseline, 2 months, 4 months, 6 months, and for the waitlist group, 8 months after enrollment. Researchers will assess satisfaction, acceptability, recruitment rates, retention, adherence to the intervention, and monitor any adverse events up to six months. Participants will also provide feedback immediately after each session to help evaluate the program's impact and safety.