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New treatment option for Major Depressive Disorder
Official title Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT05850689
What this study is testing
What is Lumateperone?
Lumateperone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female patients between the ages of 18 and 65 years, inclusive;
- Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the...
- The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
- Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
You likely can't join if
- Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary...
- Eating disorder;
See the full eligibility criteria
- Male or female patients between the ages of 18 and 65 years, inclusive;
- 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...
- The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
- Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
- Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
- 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.
- 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...
- citalopram/escitalopram
- fluoxetine
- paroxetine
- sertraline
- duloxetine
- levomilnacipran/milnacipran (if locally approved for MDD)
- venlafaxine/desvenlafaxine
- bupropion
- vilazodone
- vortioxetine
- Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- 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...
- Eating disorder;
- Substance use disorders (excluding nicotine);
- Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
- The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
- 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...
- At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
- At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
- The patient is considered to be in imminent danger to him/herself or others.
- The patient has a first MDE at age 60 years or older.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Pico Rivera, California, United States
- Farmington, Connecticut, United States
- Clermont, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Methuen, Massachusetts, United States
- O'Fallon, Missouri, United States
- Toms River, New Jersey, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Avon Lake, Ohio, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Pico Rivera, California, United States; Farmington, Connecticut, United States; Clermont, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.