Avon Lake

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.

Major depressive disorder (MDD) is a common and serious mood disorder causing persistent sadness and loss of interest, along with emotional and physical symptoms like irritability, tiredness, and changes in appetite. This trial investigates the effects of oral Icalcaprant, an experimental drug, on adults currently experiencing a major depressive episode. The study aims to assess changes in disease activity and monitor adverse events over the treatment period. Participants will be randomly assigned to one of three groups, with about one-third receiving a placebo. Those in the treatment arms will take oral capsules of Icalcaprant once daily for six weeks. After the treatment period, there will be a 30-day safety follow-up to monitor any ongoing effects or side effects. During the study, participants will visit the hospital or clinic regularly for medical assessments, blood tests, side effect monitoring, and to complete questionnaires. Researchers will evaluate changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and track the number of participants experiencing adverse events. The total participation duration includes the six-week treatment and the 30-day follow-up.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.

Researchers are evaluating the effects of lumateperone compared to a placebo in children and teens aged 10 to 17 who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well lumateperone works and how safe it is in this young population. Diagnoses are confirmed using a structured clinical interview based on DSM-5 criteria. The study includes three phases: a screening period of up to 2 weeks to check if patients qualify, a 6-week double-blind treatment phase where participants are randomly assigned to take either lumateperone or a matching placebo once daily by mouth, and a 1-week safety follow-up after the last dose for health monitoring. Lumateperone is given orally once a day, and the placebo group receives a matching oral pill on the same schedule. Participants will attend clinic visits for assessments including the Children's Depression Rating Scale-Revised (CDRS-R) measured at week 6 to evaluate depressive symptoms. Safety follow-up occurs about one week after treatment ends. Throughout the study, researchers monitor symptoms, side effects, and overall health to assess the treatment's impact and safety over the 7 to 9 week total participation time including screening and follow-up.

Researchers are evaluating lumateperone in a multicenter, randomized, double-blind, placebo-controlled phase 3 study for children aged 5 to 17 years with irritability associated with Autism Spectrum Disorder (ASD). The diagnosis of ASD is based on DSM-5-TR criteria and confirmed using the K-SADS-PL assessment. The study focuses on measuring irritability symptoms in this pediatric population. The study has three phases: a screening period up to 14 days to check eligibility, a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose. Treatments are taken orally once daily during the treatment phase. Participants and their caregivers will attend clinic visits for assessments including the Aberrant Behavior Checklist - Irritability subscale measured at week 6 to evaluate treatment effects. Safety monitoring occurs during treatment and follow-up. Caregivers must provide consent, and children may provide assent when appropriate. The total participation duration includes screening, 6 weeks of treatment, and one week of safety follow-up.

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 the safety and tolerability of lumateperone in children and adolescents aged 5 to 17 years with schizophrenia, bipolar disorder, or autism spectrum disorder. This global, multicenter, open-label Phase 3 study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. The conditions studied are confirmed using standardized diagnostic tools, and participants must generally be outpatients expected to remain so during the study. Participants will receive lumateperone once daily in doses ranging from 5 mg to 42 mg, provided as capsules or orally disintegrating tablets, adjusted by age and condition. The study includes a screening period of up to two weeks to determine eligibility, followed by a 26-week open-label treatment phase where all patients receive lumateperone. After treatment, there is a two-week safety follow-up period to monitor any lasting effects or adverse events. During the study, participants will be monitored for common adverse events up to six months. The study involves regular assessments to ensure safety and tolerability, including evaluation for suicidal risk and maintenance of outpatient status. Parents or guardians provide consent while participants provide assent. The total participation lasts approximately 30 weeks, including screening, treatment, and follow-up.

Researchers are evaluating lumateperone as an additional treatment for adults aged 18 to 65 with major depressive disorder (MDD) who have not responded adequately to current antidepressant therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of lumateperone in patients diagnosed according to the DSM-5 criteria, including those with psychotic features. Participants must have moderate to severe depression and an ongoing major depressive episode lasting between 12 weeks and 18 months. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules once daily during a six-week double-blind treatment period. Before treatment, there is a screening period of up to two weeks to confirm eligibility. After the treatment phase, there is a one-week safety follow-up visit to monitor participants after completing the study medication. Throughout the study, patients will be assessed using depression rating scales including the Montgomery-Asberg Depression Rating Scale (MADRS). Other evaluations include psychiatric interviews, symptom questionnaires, and safety monitoring for suicidal thoughts or behaviors. The study tracks changes in depression severity and safety outcomes from screening through treatment and follow-up, totaling approximately nine weeks of participation.

Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Bipolar disorder is a serious, long-lasting mood condition affecting up to 4% of adults in the United States. This research aims to evaluate the safety and effectiveness of ABBV-932, an investigational drug, in treating adults with bipolar I or II disorder who are currently experiencing a depressive episode. The study is a phase 2, open-label trial conducted at about 50 sites across the United States and Puerto Rico, enrolling approximately 200 adults aged 18 to 65 years. Participants will take ABBV-932 as oral capsules during a 26-week treatment period. After this, there will be a 30-day safety follow-up period. The study focuses on monitoring the long-term safety and tolerability of ABBV-932 in this population, with attention to adverse events and other health measures. Throughout the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, and questionnaires to track side effects and treatment effects. Researchers will measure changes in vital signs, electrocardiograms, laboratory tests, movement scales, mental health scales, and ocular exams up to 26 weeks. The total participation duration includes the treatment and follow-up periods, ensuring ongoing safety monitoring.