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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 720

Inclusion Criteria

? Male or female, aged 18 to 74 years (inclusive).
? Meet DSM-5 diagnostic criteria for MDD, without psychotic features
? 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.
? Have a HDRS-17 total score =22 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 beginning to end of screening.
? 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 37 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

? 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

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