A Study to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
- Conditions
- Major Depressive DisorderMedDRA version: 20.0Level: LLTClassification code 10025458Term: Major depressive disorder, recurrent episode, moderate degreeSystem Organ Class: 100000004873MedDRA version: 21.1Level: LLTClassification code 10081270Term: Major depressive disorderSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2021-001172-41-PL
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 760
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
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
- Primary Outcome Measures
Name Time Method Primary end point(s): Change from baseline in MADRS total score and CGI-S score.;Timepoint(s) of evaluation of this end point: From Baseline (Visit 2) to Day 43 (Visit 8);Main Objective: To evaluate the safety and tolerability of lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).;Secondary Objective: 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 Montgomery-Åsberg Depression Rating Scale (MADRS) total score and in the Clinical Global Impression Scale- Severity (CGI-S) score.<br><br>Safety Objectives<br>The purpose of the current study is to evaluate the safety and tolerability of lumateperone 42 mg as adjunctive treatment to antidepressant therapy (ADT) in patients with MDD.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Analyses of efficacy endpoints will be performed based on the patients in the Safety Population who have an available baseline efficacy value and at least one postbaseline efficacy assessment during the Open-label Treatment Period. Analyses will primarily consist of change from baseline descriptive summaries of MADRS total score and CGI-S scores.<br><br>All safety parameters will be summarized descriptively. Safety analyses will be based on the Safety Population defined as all patients who received at least one dose of open-label lumateperone 42 mg.;Timepoint(s) of evaluation of this end point: Additional efficacy parameters: every visit<br>Safety: every visit