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

This study has been completed.
Sponsor:
Information provided by:
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00878540
First received: April 8, 2009
Last updated: September 15, 2010
Last verified: September 2010
History of Changes
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1 Study of Mirtazapine in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Mirtazapine
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 25 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 8, 2009
Last Updated: September 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Mirtazapine
Mianserin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 16, 2013