Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major D… (NCT05061706) | Clinical Trial Compass
CompletedPhase 3
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
United States480 participantsStarted 2021-09-30
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion 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 MINI and meets all of the following criteria:
✓. The start of the current major depressive episode (MDE) is at least 8 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 (Visit 1) 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 to ADT (less than 50% improvement) as confirmed by the Investigator 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:
Exclusion criteria
✕. 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.
✕. Eating disorder;
✕. Substance use disorders (excluding nicotine);
✕. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;