A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Janssen-Cilag International NV0 个研究点目标入组 720 人开始时间: 2020年8月7日最近更新: 2023年12月4日

适应症

试验速览

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•? 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

•? 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.

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