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?

Phase 1

• Conditions: depressed patients and healthy control subjects; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-005239-15-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 232

Inclusion Criteria

• 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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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
• presence of cardiovascular problems (cardiac insufficiency)
• hypokalemia (potassium deficiency)
• people who are accommodated in an psychiatric institution based on an official or judicial decision
• people who are dependent on the investigator, sponsor or study centre
• known drug intolerance
• People whose laboratory test results do not meet the following eligibility limits: AST and ALT < 2 x upper limit of normal, Kreatinin < 1,5 x lower limit of normal
• People whose systolic blood pressure is outside 90 and 140 mmHg, People whose diastolic blood pressure is outside 50 and 90 mmHg, and People whose heart rate is outside 50 and 90 beats per minute
• dysfunctions of the heart (except : AV block 1st degree)
• Participation in any drug - interventional clinical trial within the last month or during the study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified