Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Max-Planck-Institute of Psychiatry
• Treatments: Mianserin; Mirtazapine

Criteria

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