Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
Conditions
Interventions
Intervention1: Lumateperone: Route: Oral
Dose: Formulated Capsules (42 mg)
Approximately 26 weeks of open-label treatment, followed by a 2-week Safety Follow-up
Control Intervention1: Not Applicable
Sponsors
Intra-Cellular Therapies, Inc.
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Each patient entering the Open-label Safety Study must meet all of the following criteria: 1. In the opinion of the Investigator, the patient must have safely completed the lead-in study. 2. The patient must understand the written informed consent for the Open-label Safety Study, provide signed and witnessed written informed consent. 3. The patient is taking his/her ADT as prescribed from the lead-in study. 4. The patient must agree to continue using highly effective methods of birth control as specified in the lead-in study through the Safety-Follow-up Period of the Open-label Safety Study, or female patients or female partners of male patients must be of non-childbearing potential.
Exclusion criteria
Exclusion criteria: Because all patients enrolled in the lead-in study were required to satisfy exclusion criteria for participation in the lead-in study, the Investigator should assess if there has been any change in patient health status. Any newly-emergent medical condition reported during the lead-in study must be evaluated by the Investigator and should be discussed with the Sponsor or designee before enrolling the patient in the study. Patients enrolling directly from the lead-in study to the Open-label Safety Study at Visit 1/Day 1 will be excluded if they meet the following criteria: 1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study 2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At the Screening/Baseline Visit (Visit 1/Day 1) the patient scores “yes ? on Suicidal Ideation Items 4 and 5 of the C-SSRS since the last visit version (Visit 7/Week 5 of the lead-in studies) b. At the Screening/Baseline Visit (Visit 1/Day 1), the patient scores > 5 on MADRS Item 10 (Suicidal Thoughts) 3. Based on the Investigator’s clinical judgement, any abnormal clinical laboratory tests results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •The primary objective of the Open-label Safety Study is to evaluate the safety and tolerability of lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to ADT in patients with MDD.Timepoint: From baseline to Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| • The secondary objective of the Open-label Safety Study is to evaluate whether lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to ADT improves or maintains improvement of depressive symptoms in patients with MDD as measured by change from baseline in the MADRS total score and change from baseline in the CGI-S scoreTimepoint: From baseline to Day 43 | — |
Countries
Argentina, Bulgaria, Colombia, Czech Republic, Finland, Germany, Hungary, India, Poland, Republic of Korea, Slovakia, Sweden, United States of America
Contacts
Public ContactJinu Jose
IQVIA RDS (India) Private Limited
Outcome results
None listed