North Canton

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on adults aged 18 to 85 who have moderate to severe depression and have not responded adequately to a stable antidepressant medication. This phase III trial aims to add knowledge about treating MDD by assessing CYB003 alongside current antidepressants and psychological support. Participants are randomly assigned to one of two groups. One group receives 16 mg of CYB003 in two dosing sessions spaced about three weeks apart, while the other group receives a placebo on the same schedule. All participants continue their current antidepressant treatments and receive manualized psychological support throughout the study. Those who do not respond to placebo may join a later extension trial to receive CYB003. Throughout the trial, participants undergo several assessments, including the Montgomery-Åsberg Depression Rating Scale (MADRS) at multiple time points from screening to 42 days after treatment begins. Other evaluations include the Beck Depression Inventory, Clinical Global Impression Scale, Generalized Anxiety Disorder scale, and Quality of Life questionnaire. Participants are monitored for safety, treatment response, and tolerability, with the total study period lasting around six weeks after dosing begins.

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.

Researchers are studying etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein that carries oxygen in the blood. This phase 3 open-label study aims to assess the long-term safety and effectiveness of etavopivat in adults, adolescents, and children who have completed treatment in an earlier etavopivat study. The study is sponsored by Novo Nordisk A/S and may last up to 264 weeks unless etavopivat is approved earlier in the participant's country. Participants will receive an oral dose of etavopivat, with dosing varying by age and condition. Those aged 12 years or older will receive either Etavopivat A or C, while children under 12 years old will receive Etavopivat B. The study includes groups with sickle cell disease or thalassaemia, some of whom may be transfusion-dependent. The treatment will be continuous throughout the study period, aiming to observe long-term effects and safety. During the study, participants will be closely monitored for treatment-emergent adverse events and adverse reactions. Researchers will track clinical outcomes such as vaso-occlusive crisis rates, hemoglobin levels, hospitalizations, and red blood cell transfusions, both at baseline and throughout treatment. Data will be collected regularly to assess safety and treatment impact across different age groups and disease types, with the total study duration potentially extending to over six years.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film (VLS-01-BU) in adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants' depressive symptoms will be regularly monitored using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are evaluating the long-term safety and tolerability of KarXT in adults with Bipolar-I disorder experiencing mania or mania with mixed features. This phase 3, open-label extension study focuses on participants who either completed specific previous clinical trials or are newly diagnosed with Bipolar-I disorder according to DSM-5-TR criteria and confirmed by psychiatric interviews. The study aims to better understand the safety profile of KarXT for managing manic episodes in this population. Participants will receive KarXT at specified doses over the course of the study, with some possibly also receiving adjuvant treatments such as lithium, valproate, or lamotrigine at therapeutic doses. The study includes an initial treatment period followed by ongoing monitoring to assess safety and tolerability. It is open-label, meaning both participants and researchers know the treatment being given. During the study, participants will undergo regular assessments including monitoring for adverse events, changes in suicidal thoughts using the Columbia-Suicide Severity Rating Scale (C-SSRS), and evaluations of movement disorders using scales such as the Barnes Akathisia Rating Scale (BARS), Simpson Angus Scale (SAS), and Abnormal Involuntary Movement Scale (AIMS). The study will last up to 54 weeks and aims to collect comprehensive safety data while participants continue treatment under medical supervision.

Researchers are evaluating the effects of KYN-5356 on adults who have cognitive impairment associated with schizophrenia (CIAS). This Phase 2 study compares the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of three different doses of KYN-5356 with a placebo over 28 days. The goal is to understand how this drug impacts brain function and cognitive abilities in this population. Participants will be randomly assigned to one of four groups: low, medium, or high dose of KYN-5356, or placebo. They will take oral tablets daily for 28 days while staying in a clinic from three days before dosing starts until the day after dosing ends. Some participants at selected sites will undergo special electrophysiological tests to assess brain activity changes from the treatment. Throughout the study, participants will have regular assessments to monitor safety, treatment effects, and drug levels in the body. After completing the treatment period and safety checks, participants will leave the clinic on Day 29 and return for a follow-up visit on Day 42. The primary measure is the drug's impact on cognitive function after 28 days of treatment.

Researchers are evaluating the efficacy and safety of KarXT for treating manic episodes in adults with Bipolar-I Disorder, including those experiencing mania with mixed features. This Phase 3, randomized, double-blind, placebo-controlled, inpatient study aims to compare KarXT to placebo during an acute episode of mania. The study is conducted at multiple centers and sponsored by Bristol-Myers Squibb. Participants will be randomly assigned to receive either KarXT or a placebo with flexible dosing during a 3-week inpatient treatment period. The study includes a screening phase followed by this double-blind treatment and then a safety follow-up. The total duration of participation, including all phases, will be no more than seven weeks. During the study, participants will undergo assessments such as the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Bipolar (CGI-BP) to measure changes in mania symptoms. Researchers will monitor response to treatment, safety, and any side effects throughout the trial. The primary measurement is the change in YMRS score at week 3, with additional evaluations of clinical improvement and response rates. Participant safety will be monitored before, during, and after treatment.

Researchers are studying the use of KarXT in adults aged 18 to 65 with Bipolar-I disorder who are experiencing an acute manic episode or mania with mixed features. This Phase 3, randomized, double-blind, placebo-controlled inpatient study aims to evaluate how well KarXT works compared to a placebo in improving manic symptoms over a 3-week treatment period. The study includes a screening phase, the inpatient treatment phase, and a safety follow-up, lasting up to seven weeks in total. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. The study compares these two groups to assess the effects on mania symptoms, with careful monitoring throughout the hospitalization. The double-blind design ensures that neither participants nor researchers know who is receiving KarXT or placebo, helping to fairly evaluate the treatment's impact. During the study, participants will be assessed using tools such as the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Bipolar (CGI-BP) scale at baseline and after three weeks. Researchers will monitor symptom changes, response rates, and safety throughout the study. The total participation time includes screening, treatment, and follow-up, lasting no more than seven weeks.

Researchers are studying the effects of SPT-300 (GlyphAllo), a prodrug of allopregnanolone, in adults with major depressive disorder (MDD), including those with or without anxious distress. This randomized, double-blind, placebo-controlled study aims to evaluate the drug's efficacy, safety, and tolerability in this population. The study is a Phase 2 trial designed to provide important information about SPT-300 as a monotherapy treatment for MDD. Participants will be randomly assigned to receive either SPT-300 capsules or a matching placebo once daily for 42 days. This parallel-group design ensures that both groups are treated similarly except for the active drug, allowing researchers to compare the effects accurately. The study focuses solely on monotherapy, meaning no additional antidepressant treatments are given during this period. During the trial, participants will be assessed at the start and after 42 days of treatment using the Hamilton Depression Rating Scale-17 (HAM-D-17) to measure changes in depression severity. Safety and tolerability will also be monitored throughout the study. Additional evaluations include the Clinical Global Impression - Severity (CGI-S) scale to assess overall illness severity. The total participation time corresponds to the 42-day treatment period, with monitoring to ensure adherence and safety.

Researchers are evaluating ACP-211 as a monotherapy for adults aged 18 to 65 with major depressive disorder (MDD) who have not had sufficient improvement with antidepressant therapy, including those with treatment-resistant depression. The study aims to determine if ACP-211 is more effective than a placebo in reducing depression symptoms and to assess adverse events experienced by participants. This is a randomized, double-blind, placebo-controlled Phase 2 clinical trial sponsored by ACADIA Pharmaceuticals Inc. Participants will be assigned randomly to one of three groups: ACP-211 600 mg taken orally twice weekly, ACP-211 300 mg taken orally twice weekly, or a matching placebo taken orally twice weekly. Treatment will continue for a period up to Day 28, during which the effects of the medication on depression symptoms will be monitored and compared across groups. Throughout the study, participants will undergo assessments including the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and Day 28 to measure changes in depression symptoms. Additional evaluations include MADRS scores at 24 hours postdose on Day 2. Safety and adverse events will be closely monitored, and participants will be evaluated at screening to confirm eligibility. The study duration includes treatment and follow-up assessments up to approximately one month.