Healthy
Conditions
Keywords
mirtazapine, metabolism, depression, Healthy males
Brief summary
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.
Interventions
DRUGmirtazapine
30 mg mirtazapine once daily for 7 days
Sponsors
Max-Planck-Institute of Psychiatry
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Male sex * Age 20-25 years * Somatically and mentally healthy * Normal body weight (body mass index (BMI)18.5-25)
Exclusion criteria
* Smoking within the last 6 months * Medication within last 6 months * Current or former psychiatric illness * Positive family history (first grade relatives) for metabolic diseases * Alcohol abuse * Current or former illicit drug abuse * Current or former drug abuse * Known intolerance to, or former prescription of study medication * Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months * Homelessness * Shift work within last 12 months * Known hypersensitivity to mirtazapine or other components of the drug given * Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease * Known hematologic disease, especially agranulocytosis or leukopenia * Blood donation within last 6 months prior to the begin of the study * Hemoglobin below 13.5 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day | 3 days |
Countries
Germany
Outcome results
None listed