Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?

Charité - Universitätsmedizin Berlin0 sites232 target enrollmentFebruary 3, 2016

Overview

No summary available.

Registry

who.int

Start Date

February 3, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•healthy adults aged 18 to 65,
•ability to provide written informed consent
•Only for patients: Diagnosis major depression according to DSM\-5 \& 18 points or more in the 17\-item Hamilton Depression Rating Scale (Hamilton, 1960\),
•effective contraception in women (defined as Pearl index \<1\), or reliable abstinence
•from any heterosexual relationships in women of childbearing potential, or postmenopausal status (amenorrhea for at least 12 months without alternative reason).
•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 232
•F.1\.3 Elderly (\>\=65 years) no

•taking psychotropic drugs (eg, antidepressants) within the last 5 days,
•substance abuse or dependence (except nicotine) within the last 6 months,
•presence of other psychiatric disorders (current or past psychosis, schizoaffective or bipolar disorder)
•presence of a neurodegenerative disease,
•existence of a current or past organic brain damage (pervasive developmental disorder, mental retardation, epilepsy, head injury with loss of consciousness)
•presence of acute suicidality,
•Treatment with fluoxetine or an injectable antipsychotic within the last 30 days.
•presence of an endocrine disorder or taking a medication with neuroendocrine effects (eg insulin dependent diabetes mellitus, taking steroids)
•existence of current pregnancy or lactation,
•non\-agreement to save and transmit pseudonymised study data within the clinical Trial