Major Depressive Disorder (MDD) MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 100000004873
Conditions
Interventions
Product Name: Seltorexant 20 mg
Product Code: JNJ-42847922
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Seltorexant
CAS Number: 1452539-75-1
Current Sponsor code: JNJ-42847922
Other descrip
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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 = 24 months. ? Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. The adequate response is defined as a stable antidepressant treatment for at least 6 weeks on a stable dose (and no greater than 18 months in the current episode) at or above the minimum therapeutic dose specified in the MGH-ATRQ and must include the participant's current antidepressant treatment. ? Have a HDRS-17 total score =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. ? Have a patient version ISI total score =15 as well as a clinician version of the ISI total score =15 at the second screening visit. ? 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 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: ? 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 six 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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to Week 26 in weight with seltorexant vs quetiapine XR.;Timepoint(s) of evaluation of this end point: Week 26 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of seltorexant compared with quetiapine XR as adjunctive therapy to an antidepressant drug in treatment response in participants with MDDIS who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI.;Secondary Objective: To assess the change in weight with seltorexant compared with quetiapine XR as adjunctive therapy to an SSRI or SNRI. To assess the efficacy of seltorexant compared with quetiapine XR as adjunctive therapy to an SSRI or SNRI on the following: • Delaying time to potentially treatment related discontinuations • Symptoms of depression • Symptoms of depression by subscales ?Core symptoms of depression ?Without Sleep Item • Patient-reported symptoms of depression • Remission of depressive symptoms • Response and mild or better symptoms of MDD • Clinically relevant weight gain;Primary end point(s): Difference in proportions of responders (=50% improvement in MADRS total score from baseline) at Week 26 for seltorexant vs quetiapine XR.;Timepoint(s) of evaluation of this end point: Week 26 | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Czechia, Czech Republic, Latvia, Lithuania, Malaysia, Poland, Puerto Rico, Russian Federation, Serbia, Slovakia, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed