A Study to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 20.0Level: LLTClassification code 10025458Term: Major depressive disorder, recurrent episode, moderate degreeSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10081270Term: Major depressive disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-001172-41-SK
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 760

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 755
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 the Screening/Baseline Visit (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 Visit 1/Day 1, the patient scores yes” on Suicidal Ideation Items 4 or 5 of the C-SSRS Since Last Visit” version;
b.At Visit 1/Day 1, the patient scores = 5 on the MADRS Item 10 (Suicidal Thoughts).
3.Based on the Investigator’s clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.
4.The patient is breast-feeding or pregnant; female patients of childbearing potential must have a negative urine pregnancy test at Visit 1/Day 1.
5.Has a positive urine drug test at Visit 1/Day 1. Positive tests attributable to prescription treatments (eg, opioids, benzodiazepines) may not be exclusionary if the use is not chronic and is able to be safely discontinued based on Investigator judgment and with the concurrence of the Sponsor or designee.
6.The patient has any other condition that may be detrimental to the patient if she/he participates in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified