BridgeMD
A study to assess the efficacy and safety of lumateperone in patients with major depressive disorder
EU CTIS ID: 2023-503836-41-00
What this study is testing
To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to antidepressant therapy in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing antidepressant therapy (ADT) as measured by change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient provides written informed consent before the initiation of any study-specific procedures;
- 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 Version (SCID-5-CT) and meets all of the following criteria: a. The start of the current major depressive episode (MDE) is at least 12 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
- Currently having an inadequate response (less than 50% improvement) to 2 or more ADT’s 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: 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
You likely can't join if
- 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;
- 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;
- The patient experiences a ≥ 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2);
- The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2);
- 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;
- 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
- India
- Serbia
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Serbia; United States. 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 EU CTIS; the study team decides eligibility.