depressed patients and healthy control subjects
Conditions
Interventions
Trade Name: Astonin H 0.1 mg
Product Name: Fludrocortison
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUDROCORTISONE
CAS Nu
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the effects of fludrocortisone versus placebo on the attention bias in a pooled group of depressive patients and healthy control subjects (measured by the „Attentional bias index“ in the emotional dot probe paradigm); Secondary Objective: Secondary objectives of the study are to investigate: - the effects of fludrocortisone versus placebo on emotion recognition in faces (“Facial recognition task”), empathy (“Multifaceted empathy task”), and spatial memory (“Virtual Water-Maze paradigm”) in a pooled group of depressive patients and healthy control subjects - the effects of a combined administration of fludrocortisone and D-cycloserin versus a single administration of fludrocortisone or D-cycloserin on attention bias, emotion recognition in faces, empathy, and spatial memory in a pooled group of depressive patients and healthy control subjects ;Primary end point(s): Attention bias (measured using an emotional dot-probe paradigm);Timepoint(s) of evaluation of this end point: three hours after intervention (administration of fludrocortisone, D-cycloserin or placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - emotion recognition in faces (measured by the number of right answers in “Facial recognition task”) - empathy (measured by the score of “Multifaceted empathy task”) - spatial memory (measured by the time spent in the correct quadrant in a test trial of the “Virtual Water-Maze paradigm) ;Timepoint(s) of evaluation of this end point: three hours after intervention (administration of fludrocortisone, D-cycloserin or placebo) | — |
Countries
Germany
Contacts
Public ContactKlinik für Psychiatrie und Psychoth
Charité - Universitätsmedizin Berlin
Outcome results
None listed