A randomised, double-blind, active placebo-controlled, parallel groups dose-response study of intravenous scopolamine in major depressive disorder

The University of Auckland0 个研究点目标入组 40 人开始时间: 2019年4月11日最近更新: 2022年8月22日

适应症

试验速览

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•Major depressive disorder for at least two weeks, as assessed by both Clinical Interview using and the Mini-International Neuropsychiatric Interview (MINI)
•A pre-trial Montgomery-Asberg Depression Rating Scale score of greater than 20
•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.
•Participant is willing and able to give informed consent for participation in the trial.

•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•Regular use of any medication deemed to be contraindicating as judged by the attending study clinicians. See
•Contraindication to the use of scopolamine or glycopyrrolate according to manufacturer guideline
•Significant renal or hepatic impairment.
•Participants with glaucoma
•Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening.
•History of psychosis.
•Any unstable medical or neurologic condition.
•Planned major changes to psychotropic medication.
•Imminent risk of suicide as determined by clinical interview.
•Problematic substance dependence in previous 3 months
•Inability to speak or read English.
•Stage 3 or higher treatment-resistant depression as defined by the Thase and Rush Staging criteria
•Patients who have been referred by their GP to a Community Mental Health Centre (CMHC) for management, or who are under the care of a CMHC.
•Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

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