Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Phase 1 Study of Mirtazapine in Healthy Subjects

The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.

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