A Double-Blind, Doubly-Randomized, Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression (SYNAPSE)

Janssen-Cilag International NV0 个研究点目标入组 108 人开始时间: 2013年11月18日最近更新: 2022年3月28日

研究概览

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•- Patient must meet Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment, and confirmed by the Mini International Psychiatric Interview (MINI).
•- Patient's major depressive episode and treatment response must be deemed valid by remote independent raters
•- Patient must have had an inadequate response to at least 2 antidepressants, at least one of which is in the current episode of depression. The ATRQ will be used to assess antidepressant treatment response during the current episode. Prior medication history will be used to determine antidepressant treatment response in prior episode(s)
•- Have an Inventory of Depressive Symptoms-Clinician rated, 30-item (IDS-C30) total score >=34 at Screening and predose at Day 1
•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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patient has a current diagnosis of bipolar and related disorders, intellectual disability, or cluster b personality disorder (e.g., borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder)
•- Patient has a current or prior diagnosis of a psychotic disorder or MDD with psychosis
•- Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; signs and symptoms of rhinitis)
•- Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, and at times has facial pain, headaches, and postnasal drip
•- Patient meets criteria for substance or alcohol use disorder, except tobacco or caffeine, according to DSM-5 criteria at Screening
•- Patient has known allergies, hypersensitivity, intolerance, or contraindication to esketamine/ketamine or its excipients

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