Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: mirtazapine

• Registration Number: NCT00878540
• Lead Sponsor: Max-Planck-Institute of Psychiatry

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mirtazapine	mirtazapine	-

Primary Outcome Measures

Name	Time	Method
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day	3 days

Trial Locations

Locations (1)

Max Planck Institue of Psychiatry; 🇩🇪 Munich, Germany