A Study to Assess the Efficacy and Safety of Lumateperone as Add on 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: EUCTR2021-001212-29-PL
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-29
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Main Inclusion Criteria
1. Provides written informed consent;
2. Male or female patients between the ages of 18 and 65 years, inclusive;
3. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor- approved rater using the MINI and meets all of the following criteria:
a. The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening (Visit 1);
b. Has at least moderate severity of illness based on rater- administered MADRS total score = 24 at Screening (Visit 1) and at Baseline (Visit 2);
c. Has at least moderate severity of illness based on CGI-S score = 4 at Screening (Visit 1) and at Baseline (Visit 2);
d. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score =14 at Screening (Visit 1) and at Baseline (Visit 2);
e. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
4. Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator using ATRQ and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:
a. citalopram/escitalopram
b. fluoxetine
c. paroxetine
d. sertraline
e. duloxetine
f. levomilnacipran/milnacipran (if locally approved for MDD)
g. venlafaxine/desvenlafaxine
h. bupropion
I. vilazodone
j. vortioxetine
All Inclusion Criteria are presented in Section 6.3.1. of the enclosed protocol
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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Main Exclusion Criteria
Patients who meet any of the following exclusion criteria will not be able to participate in the study:
1. Within the patient’s lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
a. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
b. Bipolar Disorder;
2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
a. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
b. Eating disorder;
c. Substance use disorders (excluding nicotine);
d. Personality disorder of sufficient severity to have a major impact on the patient’s psychiatric status;
e. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
3. The patient experiences a = 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2);
4. The patient experiences a = 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2);
5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
a. At Screening (Visit 1), the patient scores yes” on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline (Visit 2), the patient scores yes” on Suicidal Ideation Items 4 or 5 since the Screening Visit;
b. At Screening (Visit 1), the patient has had 1 or more suicide attempts within 2 years prior to Screening;
c. At Screening (Visit 1) or Baseline (Visit 2), the patient scores = 5 on MADRS Item 10 (Suicidal Thoughts), or
d. The patient is considered to be in imminent danger to him/herself or others.
6. The patient has a first MDE at age 60 years or older. All Exclusion Criteria are presented in Section 6.3.2. of the enclosed protocol

Study & Design

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