Overview

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