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

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. Identifier: NCT00878540
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : September 16, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: mirtazapine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Mirtazapine in Healthy Subjects
Study Start Date : September 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Mirtazapine

Arm Intervention/treatment
Experimental: mirtazapine Drug: mirtazapine
30 mg mirtazapine once daily for 7 days
Other Name: Remergil

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

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

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

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 identifier (NCT number): NCT00878540

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry Identifier: NCT00878540    
Other Study ID Numbers: L2/2008
EudraCT-Nr.: 2008-002704-26
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by Max-Planck-Institute of Psychiatry:
Healthy males
Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists