A Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2- Treatment Cross-Over Study to Evaluate the Effects of Ketamine on Resting State Functional Brain Connectivity in Major Depressive Disorder Patients who fail to respond to a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Noradrenaline Reuptake Inhibitor (SNRI) - A study to assess the effect of ketamine on depression using fMRI

Sumitomo Dainippon Pharma0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•Eligible subjects must meet all of the following inclusion criteria at screening:
•- Men or women, 18 to 65 years of age, inclusive.
•- Meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for depression, without psychotic features based upon clinical assessment at screening and confirmed by the Mini-International Neuropsychiatric Interview (MINI). Comorbid anxiety disorders with the exception of Post-Traumatic Stress Disorder (PTSD) are allowed, provided these are not the primary psychiatric diagnosis.
•- Confirmation of the psychiatric diagnosis by the attending general practitioner and/or psychiatrist.
•- Be medically stable on the basis of physical examination, 12-lead ECG, and vital signs, performed at Screening. If there are abnormalities, they must be consistent with the underlying illness in the study population.
•- Be medically stable on the basis of clinical laboratory tests performed at screening.
•- Has a Hamilton questionnaire score of * 18, at screening and randomization
•- Partial or no response to a first trial with a SSRI or SNRI despite a therapeutic dose for at least 4 weeks of treatment.

•- Current DSM-IV-TR diagnosis made by attending GP or psychiatrist, or established with the MINI of a comorbid psychotic disorder or MDD with psychotic features, bipolar or related disorders, obsessive compulsive disorder, intellectual disability, borderline personality disorder, antisocial personality disorder, histrionic personality disorder or narcissistic personality disorder
•- Patient has a history of drug or alcohol abuse or dependence according to DSM-IV criteria, except nicotine or caffeine, within 6 months before Screening.
•- Has been involuntarily committed to psychiatric hospital (current episode)

发起方

Sumitomo Dainippon Pharma