This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Max-Planck-Institute of Psychiatry Identifier:
First received: April 8, 2009
Last updated: September 15, 2010
Last verified: September 2010
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.

Condition Intervention Phase
Healthy Drug: mirtazapine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Mirtazapine in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day [ Time Frame: 3 days ]

Estimated Enrollment: 12
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mirtazapine Drug: mirtazapine
30 mg mirtazapine once daily for 7 days
Other Name: Remergil


Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00878540

Max Planck Institue of Psychiatry
Munich, Germany
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Principal Investigator: Florian Holsboer, MD, PhD Max Planck Institute of Psychiatry, Munich
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry Identifier: NCT00878540     History of Changes
Other Study ID Numbers: L2/2008
EudraCT-Nr.: 2008-002704-26
Study First Received: April 8, 2009
Last Updated: September 15, 2010

Keywords provided by Max-Planck-Institute of Psychiatry:
Healthy males

Additional relevant MeSH terms:
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation processed this record on September 19, 2017