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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878540
First Posted: April 9, 2009
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Max-Planck-Institute of Psychiatry
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878540


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00878540     History of Changes
Other Study ID Numbers: L2/2008
EudraCT-Nr.: 2008-002704-26
First Submitted: April 8, 2009
First Posted: April 9, 2009
Last Update Posted: September 16, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Mirtazapine
Mianserin
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