Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Overview

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

Full Title of Study: “Phase 1 Study of Mirtazapine in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: mirtazapine
    • 30 mg mirtazapine once daily for 7 days

Arms, Groups and Cohorts

  • Experimental: mirtazapine

Clinical Trial Outcome Measures

Primary Measures

  • Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
    • Time Frame: 3 days

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Max-Planck-Institute of Psychiatry
  • Provider of Information About this Clinical Study
    • Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry
  • Overall Official(s)
    • Florian Holsboer, MD, PhD, Principal Investigator, Max Planck Institute of Psychiatry, Munich

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