A randomised, double blind, active placebo-controlled crossover trial to evaluate the short term efficacy of an N-Methyl-D-Aspartate antagonist for patients with treatment resistant depression

niversity of Auckland0 个研究点目标入组 30 人开始时间: 2015年6月3日最近更新: 2021年11月1日

适应症

试验速览

暂无简介。

•*Participant is willing and able to give informed consent for participation in the trial.
•*Male or female, aged 18 years or above and less than 60.
•*In the Investigators’ opinion, is able and willing to comply with all trial requirements.
•*Major depressive disorder for at least three months, as assessed by a Clinical Interview using DSM-IV criteria
•*MADRS >20
•*An inadequate response to at least two antidepressants courses (Antidepressant Treatment History Form) one of which can include the current episode
•*Stable on antidepressant medication for four weeks prior to Study Day 1

•*Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•*Significant renal or hepatic impairment.
•*Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening.
•*Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
•*History of psychosis
•*Any unstable medical or neurologic condition.
•*Planned major changes to psychotropic medication.
•*Imminent risk of suicide as determined by the CSSRS.
•*Planned or probable use of ECT.
•*Substance abuse or dependence in previous 6 months.
•*Any history of abuse of ketamine or phencyclidine.
•*Contraindication to the use of ketamine according to manufacturer guidelines.
•*Planned use of ketamine, for example, for pain control.
•*Unable to fast for four hours prior to each administration of trial drug.
•*Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.
•*Body-weight <50kg or >120kg.
•*Current use of NMDA antagonist medications (e.g. memantine / amantadine / rimantadine / lamotrigine / dextromethorphan/procyclidine).
•*Inability to speak or read English.
•*Contraindications for MRI scanning

发起方

niversity of Auckland