Short-term Metabolic Effects of Mirtazapine in Healthy Subjects (SMMS)

Max-Planck-Institute of Psychiatry

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT00878540

L2/2008

EudraCT-Nr.: 2008-002704-26

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: Male

Ages: 20 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

mirtazapine

Experimental group

Treatment:

Drug: mirtazapine