Health Condition 1: F318- Other bipolar disorders
Conditions
Interventions
Intervention1: Lumateperone
: Dose: once daily
Route: oral
Duration: 6-week double-blind treatment period
Control Intervention1: Placebo: Dose: once daily Route: oral Duration: 6-week double-blind tre
Sponsors
Intra-Cellular Therapies, Inc.
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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. 2. 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. 3. Male or female patients 13 to 17 years of age, inclusive; 4. 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 6. 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 10. 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 11. 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 patie
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will not be eligible to participate in the study. Psychiatric Exclusion Criteria: 1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes: a. ADHD. 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. 2. Intellectual disability, based on Investigator opinion and DSM-5 criteria. 3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization; 4. 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 5. 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. b. 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 6. 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; 7. 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; 8. Use of any strong or moderate cytochrome P450 3A4 inhibitor or any cytochrome P450 3A4 inducer within 7 days prior to Baseline (Visit 2) 9. Use of monoamine oxidase inhibitors within 14 days prior to Baseline (Visit 2) 10. Current treatment with clozapine 11. On stable treatment with valproate or lithium at the time of Screening (Visit 1) as determined by the Investigator 12. Unable or unwilling to discontinue other antipsychotics or other mood stabilizers or antidepressants prior to randomization (Baseline/Visit 2) 13. 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]) 14. 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 15. The patient has received a depot/long-acting injectable antipsychotic medication within 2 treatment cycles prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ScoreTimepoint: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) scoreTimepoint: Week 6 | — |
Countries
Argentina, India, Serbia, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed