CTRI/2025/01/079663尚未招募3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated with Bipolar I or Bipolar II disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 384
- 试验地点
- 14
- 主要终点
- to evaluate the efficacy of lumateperone vs placebo for the treatment of major depressive disorders (MEDs) associated with bipolar 1 or bipolar II disorder (bipolar depression) in pediatric patients aged 10 to 17 years as measured by the change from baseline to the end of Week 6 in the Childrens Depression Rating Scale, revised (CDRS R) Total Score
研究概览
简要总结
A Phase 3, global, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of lumateperone as treatment for pediatric patients experiencing MDEs associated with bipolar I or bipolar II disorder.
The study will be conducted as follows:
A Screening Period of up to 2 weeks during which patient eligibility will be assessed. Short extensions to the Screening Period may be granted by the Sponsor or designee in exceptional circumstances. If the site has the capacity for inpatient confinement, patients may be admitted as inpatients during the Screening Period for a monitored washout of prohibited medications for bipolar depression. The option for inpatient confinement is for safety, as determined by the investigator. If a patient is not able to transition to outpatient status at the baseline visit, they must be screen failed and returned to standard of care treatment.
A 6-week Double-blind Treatment Period (DBTP):
o At Baseline (Visit 2) patients who continue to meet all eligibility criteria will be randomized to either lumateperone or placebo o Randomization will be stratified based on age group (10 to 12 years or 13 to 17 years), region (US or non-US), and bipolar disorder type (bipolar I or bipolar II disorder).
o The first dose of study drug will be administered at the study center on Day 1
(Baseline/Visit 2)
o Starting on Day 2 and through the end of the DBTP, under LAR supervision, study drug will be orally self-administered at home once daily, at approximately the same time each evening, with or without food.
A 1-week Safety Follow-up (SFU) period during which no lumateperone will be administered. With the exception of patients enrolling directly into the open-label safety study, all patients should return to the clinic for the SFU visit approximately one week after Visit 8/early termination (ET). Patients may start/resume standard-of-care treatment as needed per physician discretion.
Patients who safely complete the 6-week DBTP may enroll in a 6-month open-label safety study at Visit 8 (Week 6) if they meet eligibility criteria and if they are considered by the Investigator to be ppropriate to participate in the 6-month, open-label safety study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •To be eligible to participate in the study, patients must meet the following inclusion criteria: 1.All patients must have an LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patients condition, and accompany the patient to study visits.
- •NOTE: Patients who turn 18 years of age during their participation in this study will be allowed to continue for the duration of this trial.
- •Able to provide consent as follows: a.
- •The patients LAR must provide written, informed consent.
- •If a patient turns the age of majority (generally, age 18 years in most jurisdictions) during study participation, they should sign the informed consent at the visit following their birthday; b.
- •The patient must provide written assent.
- •Male or female patients 13 to 17 years of age, inclusive;
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) 5.Subject has a lifetime history of at least one manic or hypomanic episode.
- •A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history
- •CDRS-R total score more than equals to 45 with more than equals to 5 on Item 11 (depressed feelings) based on Best Description of the Child at Screening (Visit 1) and Baseline (Visit 2) 7.YMRS score less than equals to 15 (with YMRS Item 1 [elevated mood] score less than equals to 2) at screening and Baseline 8.Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study, with the exception of optional inpatient confinement during the Screening Period during which patients will be monitored for safety during washout of prohibited medications for bipolar depression 9.Female patients of childbearing potential must have negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and a.
- •Are not sexually active and agree to remain abstinent from Screening through the SFU Period, or b.
- •Agree to use at least an acceptable contraceptive method (including but not limited to: hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from Screening through the SFU Period
- •Male patients who have reached spermarche must meet one of the following criteria a)Are not sexually active and agree to remain abstinent from Screening through the SFU Period b.
- •Agree to use at least an acceptable contraceptive method from Screening through the SFU period NOTE: If a male patient experiences spermarche during study participation, the Investigator should have an age-appropriate discussion with the patient and LAR to determine if contraceptive requirements (as noted above) are met
- •Body mass index (BMI) greater than the 5th percentile according to age- and genderspecific CDC Clinical Growth Charts (2000) at Screening 12.Ability to swallow capsules 13.In the opinion of the Investigator, the LAR and patient are willing to comply with all Investigator and staff instructions.
排除标准
- •Patients who meet any of the following exclusion criteria will not be eligible to participate in the study.
- •Psychiatric Exclusion Criteria:
- •Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder.
- •Exception includes: a.
- •If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
- •This must be confirmed by the Investigator and noted in the source records.
- •Intellectual disability, based on Investigator opinion and DSM-5 criteria.
- •Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
- •Demonstrates a more than equals to 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline (Visit 2) based on Best Description of the Child
- •In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or a.
- •At Screening (Visit 1), the patient scores yes on Suicidal Ideation Items 3, 4, or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline (Visit 2), the patient scores yes on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit.
- •At Screening (Visit 1), the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or d.
- •The patient is considered to be an imminent danger to him/herself or others
- •Electroconvulsive therapy (ECT), vagal nerve stimulation, repetitive trans-cranial magnetic stimulation or any other neuromodulation therapies for any CNS and psychiatry indications within the 6 months prior to Screening;
- •Likely allergy or sensitivity to lumateperone or its excipients, based on known allergies or hypersensitivities to drugs with shared pharmacology which may be suggestive of an increased potential for an adverse reaction to lumateperone;
- •Use of any strong or moderate cytochrome P450 3A4 inhibitor or any cytochrome P450 3A4 inducer within 7 days prior to Baseline (Visit 2)
- •Current treatment with clozapine
- •On stable treatment with valproate or lithium at the time of Screening (Visit 1) as determined by the Investigator
- •Unable or unwilling to discontinue other antipsychotics or other mood stabilizers or antidepressants prior to randomization (Baseline/Visit 2)
- •Use of benzodiazepines and non-benzodiazepine sleep aids (exceptions for lorazepam and other alternative treatments for insomnia as described in Section 7.8.2 [Concomitant Medications])
- •The patient has a positive test for alcohol or drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, or opioids/opiates) at Screening (Visit 1).
- •Exceptions may include prescription treatments (eg, opioids, benzodiazepines) if the use is not chronic and is able to be discontinued/restricted as per the Investigator with the concurrence of the Sponsor or designee.
- •A repeat drug test is allowed with the approval of the Sponsor or designee
- •The patient has received a depot/long-acting injectable antipsychotic medication within 2 treatment cycles prior to dosing with study drug
- •The patient is unable to be safely discontinued from prohibited medications in the opinion of the Investigator 17.Female patient who is currently pregnant or breastfeeding 18.The patient has abnormal laboratory values or clinical findings at Screening/Visit 1 that are judged to be clinically significant including, but not limited to 19.History of human immunodeficiency (HIV) infection 20.Clinically significant abnormality within 2 years of Screening that in the Investigators opinion may place the patient at risk or interfere with study outcome variables; this includes, but is not limited to, history or clinical presentation of a neurodevelopmental disorder or history of other clinically significant neurologic, hepatic, renal, gastrointestinal, respiratory, hematologic, endocrine, or immunologic disease or history of malignancy 21.Patients with a history of orthostatic hypotension or who have orthostatic hypotension (reduction of more than equals to 20 mm Hg in systolic blood pressure [SBP] or a reduction of more than equals to 10 mm Hg in diastolic blood pressure [DBP] while changing from the supine to standing position) at Screening or Baseline 22.Surgical or medical condition (active or chronic) that in the Investigators opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk 23.Documented history of chromosomal disorder with developmental impairment (eg, trisomy chromosome 21; 22q11 deletion syndrome) 24.History of seizures, with the exception of febrile seizures 25.History of significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures Additional exclusions
- •The patient is judged by the Investigator to be inappropriate for the study 27.The patient is an employee of the Investigator or study site, or immediate family (ie, child, or sibling, whether biological or legally adopted) of such employees, the Investigator, the Sponsor, or contract research organizations (CROs) conducting the study.
结局指标
主要结局
to evaluate the efficacy of lumateperone vs placebo for the treatment of major depressive disorders (MEDs) associated with bipolar 1 or bipolar II disorder (bipolar depression) in pediatric patients aged 10 to 17 years as measured by the change from baseline to the end of Week 6 in the Childrens Depression Rating Scale, revised (CDRS R) Total Score
时间窗: Week 6
次要结局
- To evaluate the efficacy of lumateperone vs placebo for the treatment of bipolar depression in pediatric patients aged 10 to 17 years as measured by the change from baseline to the end of Week 6 in the Clinical Global Impression Scale-Severity (CGI-S) score(Week 6)
研究者
研究点 (14)
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