A randomized , double-blind, placebo-controlled study of antidepressant effects of the endogen compound neuropeptide y (NPY) in patients suffering from major depressive disorder

Karolinska University Hospital, Huddinge0 个研究点目标入组 70 人开始时间: 2014年3月25日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•1.Male and female patients, age =25
•2.Signed informed consent
•3.Patients diagnosed with recurrent major depression according to DSM-5 confirmed with SCID, and a history of at least one previous episode, currently in treatment with a minimum MADRS-M score of 28
•4.Female patient of child bearing age must be willing to ensure that they use effective contraception during the study (e.g. combination of barrier method and spermicide; sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomised partner)
•5.Patient has acceptable laboratory, vital signs and ECG results (as judged by the investigator)
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Any changes in antidepressant treatment within 3 weeks before study inclusion
•2.Current manic or mixed affective episode or schizoaffective disease as well as patients with suicide risk
•3. Nasal pathology (e.g. chronic rhinitis) that can affect the uptake of NPY
•4.Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
•5.Current substance abuse or dependence
•6.Female patient who is pregnant, lactating or planning pregnancy during the course of the trial
•7.Positive alcohol breath test
•8.Participation in another study with an investigational drug within 3 months before study inclusion

发起方

Karolinska University Hospital, Huddinge