Major Depressive Disorder (MDD) MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: ? Male or female, aged 18 to 74 years (inclusive). ? Meet DSM-5 diagnostic criteria for MDD, without psychotic features The length of the current depressive episode must be =20 at the first screening interview and must not demonstrate a clinically significant improvement (ie. an improvement of >20% on their HDRS-17 total score) from the first to the second independent HDRS-17 rating, and must have a HDRS-17 total score >=18 at the second screening interview. ? Body mass index (BMI) between 18 and 40 kg/m2 inclusive (BMI=weight/height2). Note: other protocol inclusion criteria may also apply. 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 440 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: ? Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or history of suicidal behavior within the past 6 months ? Has a history of treatment resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode ? Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa or fibromyalgia. These disorders need to be in remission for at least 1 year for the participant to be enrolled. ? Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders. ? Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed. ? Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse ? Has an unstable medical condition such as diabetes, thyroid disease, renal insufficiency, or hepatic disease. Stable illnesses may be allowed. Note: other protocol exclusion criteria may also apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of seltorexant 20 mg compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with MDDIS (major depressive disorder with insomnia symptoms) who have had an inadequate response to current antidepressant therapy with an SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin-norepinephrine reuptake inhibitor);Secondary Objective: To assess the efficacy of seltorexant compared with placebo in participants with MDDIS, as adjunctive therapy to an antidepressant on patient-reported assessment of sleep outcomes To assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in participants with MDDIS on the following: - MDD symptoms other than insomnia symptoms - Patient-reported assessment of sleep outcomes To assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressants in participants with MDDIS on the following: - Core symptoms of depression - Response of depressive symptoms - Patient-reported symptoms of depression To assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with MDD ;Primary end point(s): Change from baseline to Day 43 in the MADRS total score in participants with MDDIS.;Timepoint(s) of evaluation of this end point: Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Have a HDRS-17 total score >=22 at the first screening visit and must not demonstrate improvement >20% from the beginning to end of screening - Patient-reported assessment of sleep outcomes ;Timepoint(s) of evaluation of this end point: Day 43 | — |
Countries
Brazil, Bulgaria, Chile, Colombia, Czechia, Czech Republic, Mexico, Russian Federation, South Africa, Spain, Sweden, Taiwan, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed