Overview
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2010-07-01
2010-07-01
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Max-Planck-Institute of PsychiatryTreatments:
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