An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder - Not applicable

Intra-Cellular Therapies, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•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.

•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

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