Status:
COMPLETED
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Conditions:
Healthy
Eligibility:
MALE
20-25 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Male sex
- Age 20-25 years
- Somatically and mentally healthy
- Normal body weight (body mass index (BMI)18.5-25)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00878540
Start Date
September 1 2008
End Date
July 1 2010
Last Update
September 16 2010
Active Locations (1)
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1
Max Planck Institue of Psychiatry
Munich, Germany