A study to evaluate the safety and efficacy of Seltorexant compared to Quetiapine in patients with major depressive disorder (MDD) with sleep problems who have not responded well to their current depression medicatio
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-000341-14-BG
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 720
? 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 visit 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
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method