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Completed

NCT Number: NCT00878540

Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

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

Completed

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Key information

Conditions

Healthy Behavior Behavioral Symptoms Depression

Age range

20 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Max Planck Institue of Psychiatry

Munich, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mirtazapine

Drug

30 mg mirtazapine once daily for 7 days

Other names: Remergil

Primary outcomes

  1. Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

Phase 1 Study of Mirtazapine in Healthy Subjects

Acronym: SMMS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2009
Registry last updated
Sep 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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