Avon Lake

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.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.

Researchers are evaluating the long-term safety and tolerability of NBI-1065845 as an additional treatment for adults with Major Depressive Disorder MDD. This Phase 3, open-label study focuses on participants who have a primary diagnosis of recurrent moderate or severe MDD or persistent depressive disorder and have had an inadequate response to oral antidepressant treatments in their current depressive episode. Participants will receive NBI-1065845 tablets taken orally once daily as an adjunctive therapy alongside their ongoing antidepressant treatments. The study is designed as a single-group, open-label trial without placebo or comparison groups. The treatment period and follow-up extend over 52 weeks, during which safety and tolerability will be closely monitored. Throughout the study, participants will be assessed for treatment-emergent adverse events TEAEs from baseline through Week 52. Participants must be willing and able to comply with all study procedures and restrictions, including regular visits and evaluations determined by the investigators. The overall study duration allows for comprehensive monitoring of safety outcomes and participant well-being.

Researchers are evaluating lumateperone for treating bipolar depression in children and teens aged 10 to 17 years who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the effects of lumateperone compared to placebo in this pediatric population. Participants will be randomly assigned to receive either lumateperone or a matching placebo once daily for 6 weeks. The dosage for lumateperone is 42 mg for patients aged 13 to 17 years and 21 mg for those aged 10 to 12 years. The study includes three phases up to 2 weeks of screening to confirm eligibility, 6 weeks of double-blind treatment, and a 1-week safety follow-up visit after the last dose. During the study, participants will undergo assessments including the Childrens Depression Rating Scale-Revised CDRS-R at week 6 to measure depressive symptoms. Safety will be monitored throughout, with a follow-up visit approximately one week after treatment ends. The total participation duration covers screening, treatment, and safety follow-up, ensuring comprehensive evaluation of both efficacy and safety in this age group.

Researchers are evaluating lumateperone for treating irritability in children and adolescents aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD. This randomized, double-blind, placebo-controlled study focuses on pediatric patients with confirmed ASD diagnosis and irritability symptoms as measured by specific behavioral scales. Participants will be randomly assigned to receive either a high dose or low dose of lumateperone, or a placebo, taken orally once daily during a 6-week double-blind treatment period. The study includes a screening period up to 14 days to confirm eligibility, followed by a 1-week safety follow-up visit after the last dose. During the trial, participants will undergo assessments including behavior checklists for irritability and clinical global impression scales at week 6. Safety and tolerability will be monitored throughout the study. The total participation time includes screening, 6 weeks of treatment, and a safety follow-up week, with regular visits to the clinic for evaluations.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.

This research aims to evaluate the safety and tolerability of lumateperone in pediatric patients diagnosed with schizophrenia, bipolar disorder, or autism spectrum disorder. It is a global, multicenter, open-label study lasting 26 weeks. The study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. Participants will receive lumateperone capsules or orally disintegrating tablets once daily, with doses ranging from 5 mg to 42 mg, adjusted by age and condition. The study begins with up to a 2-week screening period to confirm eligibility, followed by a 26-week open-label treatment period where all patients receive lumateperone. After the treatment period, there is a 2-week safety follow-up visit to monitor participants after their last dose. During the study, participants will be monitored regularly through clinic visits, where safety and tolerability will be assessed. Researchers will track the incidence of common adverse events throughout the 6-month treatment and follow-up period. Participants must maintain outpatient status during the trial. The total participation duration spans approximately 28 weeks, including screening, treatment, and safety follow-up.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled study to evaluate lumateperone as an additional treatment for adults with Major Depressive Disorder MDD who have not responded well to ongoing antidepressant therapy. The study focuses on patients diagnosed with MDD according to DSM-5 criteria, including those with psychotic features, who have experienced an inadequate response to at least two antidepressant treatments during their current major depressive episode. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules taken orally once daily for six weeks during the double-blind treatment period. The trial includes three periods a screening period of up to two weeks to assess eligibility, the six-week treatment period, and a one-week safety follow-up period after the last dose to monitor participant safety. During the study, participants will undergo assessments including depression severity ratings using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale. Researchers will monitor symptoms, treatment adherence, and safety throughout the treatment and follow-up periods. Total participation spans approximately nine weeks, covering screening, treatment, and safety monitoring.

This research aims to evaluate the safety and effectiveness of ABBV-932 when added to antidepressant therapies ADTs in adults with generalized anxiety disorder GAD who have not adequately responded to ADTs alone. The study is a Phase 2, randomized, double-blind, placebo-controlled trial involving approximately 315 adult participants across about 50 sites in the United States and Puerto Rico. ABBV-932 is an investigational oral drug developed as an adjunct treatment for GAD. Participants will be randomly assigned to one of three groups two different doses of ABBV-932 added to their prescribed ADTs, or a placebo added to their ADTs. The treatment period lasts for 6 weeks, during which participants will take oral capsules of ABBV-932 or placebo alongside their ongoing antidepressant treatment. Following the treatment, there is a 4-week follow-up period to monitor outcomes and safety. During the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, side effect monitoring, and questionnaires will be conducted to evaluate the treatments impact. The main outcomes measured include the number of adverse events and changes in anxiety levels assessed by the Hamilton Anxiety Scale. Additional assessments include worry questionnaires and depression rating scales. The total participation time is approximately 10 weeks, covering treatment and follow-up.

Bipolar disorder is a serious long-term mood condition affecting up to 4% of adults in the United States. This research evaluates the safety and effects of ABBV-932, an investigational drug, in adults experiencing depressive episodes related to bipolar I or II disorder. The study aims to understand how well ABBV-932 works and its safety profile for this specific group. Participants will take oral ABBV-932 capsules for 26 weeks during the treatment phase. After this, there will be a 30-day safety follow-up period to monitor any ongoing effects or side effects. The study is open-label, so all participants receive ABBV-932, and no placebo group is involved. During the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will track various safety measures including vital signs, ECG changes, lab tests, and symptom scales related to movement, sleepiness, mood, and suicidal thoughts. The total participation time includes the treatment period plus the follow-up, lasting approximately 27 weeks.