Health Condition 1: F208- Other schizophrenia
Conditions
Interventions
Intervention1: Lumateperone: Dose: once daily
Route: oral
Duration: The maximum per-patient study duration will be approximately 28 weeks
Control Intervention1: Comparator is not applicable in the st
Sponsors
Intra-Cellular Therapies, Inc.
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
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 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. 2. 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. 3. The patient must provide written assent, if developmentally appropriate. 4. 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). b. 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. 5. Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. 6. 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. 8. Male patients who have reached spermarche must meet one of the following criteria: 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 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. 9. Body mass index (BMI) greater than the 5th percentile at Baseline based on age- and gender-specific CDC Clinical Growth Charts (2000); 10. Ability to swallow capsules; 11. Ability to follow study instructions and likely to complete all required visits
Exclusion criteria
Exclusion criteria: A patient who meets any of the following exclusion criteria will not be eligible for enrollment in this study. Psychiatric Exclusion Criteria: 1. 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. The patient is considered to be an imminent danger to him/herself or others. Treatment-related Exclusion Criteria: 3. 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); 4. 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; 5. Use of any strong or moderate cytochrome P450 3A4 inhibitor or any P450 3A4 inducer within 7 days prior to Baseline (Visit 2); 6. Use of monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2); 7. Use of clozapine within 3 months prior to Baseline (Visit 2) 8. Use of antipsychotics which cannot be discontinued prior to Baseline (Visit 2). 9. 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. 10. The patient has received a depot antipsychotic within 2 treatment cycles prior to Baseline (Visit 2) 11. The patient is unable to be safely discontinued from prohibited medications (in the opinion of the Investigator). 12. 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 13. Female patient who is currently pregnant or breastfeeding; 14. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Change from baseline in Young Mania Rating Scale (YMRS) total score.Timepoint: The safety parameters will include AEs clinical laboratory vital sign ECGs EPS assessments (AIMS BARS & SAS) & C-SSRS. | — |
Countries
India, Serbia, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed