CTRI/2025/05/087417尚未招募3 期
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or autism spectrum disorder
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- To evaluate the safety and tolerability of lumateperone administered orally once daily for approximately 26 weeks in pediatric patients aged 10 to 17 years with bipolar disorder.
研究概览
简要总结
Multicenter, global, 26-week, open-label (OL) study to assess the safety and tolerability of lumateperone in pediatric patients with bipolar disorder.
The study in India will enroll pediatric patients with the following primary psychiatric diagnosis:
• Bipolar Disorder (aged 10 to 17 years)
• Patients must have completed the bipolar depression lead-in efficacy study (Study ITI-007-421)
• Patients will enroll directly from Study ITI-007-421: Visit 8 of the lead-in study will serve as the Baseline Visit (Visit 2) of this long-term safety study.
This study will be conducted as follows:
• A 26-week Open-label Treatment Period (OLTP) during which all patients will receive lumateperone once daily.
• A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU Visit (Visit 14) approximately 2 weeks after the last dose of lumateperone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •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 OL safety study will be allowed to continue for the duration of this trial.
- •In addition, patients who turn 18 years of age during a lead-in efficacy study will be allowed to enroll and continue for the duration of this trial.
- •The 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.
- •The patient must provide written assent, if developmentally appropriate.
- •Male or female patients must have a DSM-5-TR primary diagnosis of bipolar I or bipolar II disorder and meet the following: a.
- •Patients must complete the bipolar disorder lead-in efficacy study (Study ITI-007-421).
- •Patients must be aged 10 to 17 years at Screening of the lead-in study.
- •In this India original protocol, only patients aged 13 to 17 years will be eligible for enrollment.
- •NOTE: At a later date when data are available to support dose selection, this protocol will be amended to also include patients aged 10 to 12 years with bipolar disorder.
- •Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
- •Female patients of childbearing potential must have negative urine pregnancy test at Visit 8 of lead in Study ITI-007-421 and: a.
- •Are not sexually active and agree to remain abstinent from Baseline 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 Baseline through the SFU Period.
- •NOTE: If a female patient reaches menarche during the study, the Investigator should have an age-appropriate discussion with the patient and LAR to determine if contraceptive requirements (as noted above) are met.
- •Male patients who have reached spermarche must meet one of the following criteria: a.
- •Agree to use at least an acceptable contraceptive method from Baseline 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 at Baseline based on age- and gender-specific CDC Clinical Growth Charts (2000);
- •Ability to swallow capsules;
- •Ability to follow study instructions and likely to complete all required visits.
排除标准
- •A patient who meets any of the following exclusion criteria will not be eligible for enrollment in this study.
- •Psychiatric Exclusion Criteria:
- •Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder.
- •Patients with bipolar disorder with psychotic features are not allowed.
- •Note: An exception includes attention deficit hyperactivity disorder (ADHD): If a patient is taking medication(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening.
- •The treatment regimen should remain stable throughout the study.
- •This must be confirmed by the Investigator and noted in the source records.
- •2.In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or a.
- •At Baseline (Visit 2), the patient scores “yes†on Suicidal Ideation Items 3, 4, or 5 of the Columbia–Suicide Severity Rating Scale (C-SSRS) since the previous visit; or b.
- •At Baseline (Visit 2), scores greater than 3 on Item 13 (suicidal ideation) of the CDRS-R; or c.
- •Treatment-related Exclusion Criteria:
- •Received electroconvulsive therapy (ECT), vagal nerve stimulation, repetitive transcranial magnetic stimulation, or any other neuromodulation therapies for any central nervous system and psychiatry indications within 6 months prior to Baseline (Visit 2);
- •History of clinically significant drug allergy or sensitivity, including a known sensitivity or idiosyncratic reaction to lumateperone or drugs of the same class, or any compound listed in the study formulation;
- •Use of any strong or moderate cytochrome P450 3A4 inhibitor or any P450 3A4 inducer within 7 days prior to Baseline (Visit 2);
- •Use of monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2);
- •Use of clozapine within 3 months prior to Baseline (Visit 2)
- •Use of antipsychotics which cannot be discontinued prior to Baseline (Visit 2).
- •The patient had a positive test for drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opioids/opiates) or alcohol at the most recent available lead-in study assessment.
- •Exceptions may be made for appropriate prescription medication use.
- •The patient has received a depot antipsychotic within 2 treatment cycles prior to Baseline (Visit 2)
- •The patient is unable to be safely discontinued from prohibited medications (in the opinion of the Investigator).
- •The patient has had exposure to any investigational product within 3 months of Baseline (Visit 2) (except for those patients who had participated in the lead-in study) or participated in the past 3 years in greater than 2 clinical studies of an investigational product with a central nervous system indication; Other Medical Exclusion Criteria
- •Based on the most recent available assessment from the lead-in study, the patient has abnormal laboratory values or clinical findings that are judged to be clinically significant including, but not limited to: a.
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 2 × the upper limit of normal (ULN); b.
- •Total bilirubin greater than ULN c.
- •Hemoglobin less than 8 g/dL (80 g/L) for females and less than 9 g/dL (90 g/L) for males; d.
- •Thyroid-stimulating hormone (TSH) outside of the normal reference range and clinically significant, as determined by the Investigator.
- •Free T3 and free T4 will be measured if TSH level is out of range.
- •HbA1c greater than 6.5% [greater than 48 mmol/mol]; g.
- •Positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M at Screening (Visit 1) of the lead-in study; positive hepatitis C antibody at Screening (Visit 1) of the lead-in study, with the exception of a patient for whom the reflex HCV RNA test is negative; h.
- •Any other clinically significant abnormal laboratory result
- •History of human immunodeficiency (HIV) infection;
- •From the most recent assessment from a lead-in study, history of a clinically significant cardiac disorder and/or abnormal electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula (QTcF) greater than 460 msec;
- •Clinically significant abnormality within 2 years of Baseline that in the Investigator’s opinion may place the patient at risk or interfere with study outcome variables; this includes, but is not limited to, history of other clinically significant neurologic, hepatic, renal, gastrointestinal, respiratory, hematologic, endocrine, or immunologic disease or history of malignancy
- •Patients with a history of orthostatic hypotension or who have orthostatic hypotension (defined as reduction of greater than or equal to 20 mm Hg in systolic blood pressure [SBP] or a reduction of greater than or equal to 10 mm Hg in diastolic blood pressure [DBP] while changing from the supine to standing position) at the most recent available assessment from the lead-in study;
- •Surgical or medical condition (active or chronic) that in the Investigator’s 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; Additional Exclusions
- •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 safety and tolerability of lumateperone administered orally once daily for approximately 26 weeks in pediatric patients aged 10 to 17 years with bipolar disorder.
时间窗: To evaluate the safety and tolerability of lumateperone administered orally once daily for approximately 26 weeks in pediatric patients aged 10 to 17 years with bipolar disorder.
次要结局
- To evaluate whether lumateperone administered orally once daily for approximately 26 weeks improves or maintains improvement of symptoms based on:(Change from baseline in Childrens Depression Rating Scale Revised (CDRS-R) total score)
研究者
研究点 (12)
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