Healthy volunteers
Conditions
Interventions
Trade Name: Cipralex
Product Name: Escitalopram
Product Code: Lu 26-054
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade N
Sponsors
Siegfried Kasper, O.Univ.Prof.Dr.Dr.h.c.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 - 55 years. Male or female healthy volunteers. No history of drug or alcohol abuse. Normal laboratory values. Normotension (blood pressure less than 140/90). No past or present history of psychiatric disorders or major medical illness. Negative urine pregnancy test in women at the screening visit & prior to each fMRI Signed informed consent form. 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinically relevant abnormalities on a general physical examination and routine laboratory screening. Ingestion of any medication that might interfere with the study medication within 4 week prior to screening visit. Family history of diabetes or obesity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measurements of task-specific neural activity in cortical and subcortical areas of the brain will be carried out on a 3 Tesla functional magnetic resonance (fMRI) scanner providing high spatial and temporal resolution. Plasma levels of Escitalopram and Citalopram will be correlated with topological and temporal patterns of BOLD change (fMRI) in response to neural activity. To test the hypothesis that Escitalopram and Citalopram reduce hyperactivity of limbic areas, subjects will perform an emotion paradigm and two control paradigms (motor task, cognitive task/WCST) during each fMRI session. ;Secondary Objective: Following hypotheses will be tested in this study: 1. Excitability of the limbic system (including amgygdala and cingulate cortex) to emotional stimuli will be negatively correlated with plasma levels of Escitalopram and Citalopram. 2. Excitability of the limbic system will be significantly reduced after treatment with Escitalopram (10mg/d) and Citalopram (20mg/d). 3. Reduction will be significantly more pronounced after treatment with Escitalopram (10mg/d) compared to Citalopram (20mg/d). ;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed