Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Launched by INTRA-CELLULAR THERAPIES, INC. · Apr 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lumateperone to see if it can help people with Major Depressive Disorder (MDD) who aren't getting enough relief from their current antidepressant treatments. The study is looking for adults aged 18 to 65 who have been experiencing depression for at least 12 weeks but not more than 18 months, and who have not responded well to two or more antidepressant medications. Participants will be randomly assigned to receive either Lumateperone or a placebo (a pill that looks like the medication but has no active ingredients) to compare how well they work.

If you or someone you know is interested in participating, it's important to know that this study is currently recruiting patients. Eligible participants will need to have moderate to severe symptoms of depression and must be taking a stable dose of antidepressants for at least six weeks without seeing significant improvement. Throughout the trial, participants will attend regular visits with the study team to monitor their progress and any side effects. This research is essential for finding better treatment options for those struggling with depression, and your involvement could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients between the ages of 18 and 65 years, inclusive;
• 2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:
• • 1. The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
• • 2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
• • 3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
• • 4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
• • 5. 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.
• 3. Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (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:
• • 1. citalopram/escitalopram
• • 2. fluoxetine
• • 3. paroxetine
• • 4. sertraline
• • 5. duloxetine
• • 6. levomilnacipran/milnacipran (if locally approved for MDD)
• • 7. venlafaxine/desvenlafaxine
• • 8. bupropion
• • 9. vilazodone
• • 10. vortioxetine
• Exclusion Criteria:
• 1. Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
• • 1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
• • 2. Bipolar Disorder;
• 2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
• • 1. 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;
• • 2. Eating disorder;
• • 3. Substance use disorders (excluding nicotine);
• • 4. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
• • 5. 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 and Baseline;
• • 4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
• 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
• • 1. At Screening, 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, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
• • 2. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• • 3. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
• • 4. 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.