The effects of esketamine and treatment expectation in acute major depressive disorder:A pharmacological fMRI-study - Expect

Phillips Universität Marburg0 sites165 target enrollmentStarted: March 22, 2021Last updated: August 19, 2024

Overview

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•1\. a current depressive episode lasting at least four weeks
•2\. an initial score of at least 7 (corresponding to a mild degree of depression) on the Montgomery Åsberg Depression Rating Scale (MADRS)
•3\. Negative serum pregnancy test in women of childbearing potential.
•4\. Patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal
•contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.

•1\. psychotic symptoms (ascertained using SCID\-5 Interview measured by module A\-E)
•2\. acute suicidality (clinical assessment by study physician)
•3\. hypertension \> 180/100 mmHg (according to resting blood pressure, as assessed by study physician using blood pressure measurement)
•4\. hyperthyroidism that has not been sufficiently treated (clinical history by study physician and current thyroid parameters will have to be within the following ranges: TSH 0,34\-5,6 mU/l, fT3 3,2\-6,9 pmol/l, fT4 7,5\-21 pmol/l)
•5\. severe hepatic impairment (clinical history by study physician and current liver parameters will have to be within the following ranges: serum albumin \<2,8 g/dl serum bilirubin \> 3,0mg/dl, prothrombin time \< 40 % or INR \> 2,3\)
•6\. hypersensitivity to the active substance of esketamine or to any of the excipients listed in section 6\.1 of the SmPC (clinical history by study physician)
•7\. unstable angina or myocardial infarction in the last 6 months (clinical history by study physician)
•8\. Myocardial failure (clinical history and physical examination by study physician)
•9\. Glaucoma or perforating eye injuries (clinical history by study physician)
•10\. patients will be excluded if they have any drug or alcohol dependency/abuse within the previous three months or if they are under acute influence of alcohol (clinical assessment by study physician and alcohol breath test)

Sponsor

Phillips Universität Marburg