A study to evaluate the safety and efficacy of Seltorexant in patients with major depressive disorder (MDD) who have not responded well to their current depression medicatio

Phase 1

• Conditions: Major Depressive Disorder (MDD); MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000337-40-BG
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

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 <=24 months prior to randomization
? 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 an antidepressant treatment for at least 6 weeks on a stable dose (and no greater than 18 months in the current episode) or above the minimum therapeutic dose specified in the MGH-ATRQ, 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.
? 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified