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

M

Max-Planck-Institute of Psychiatry

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: mirtazapine

Study type

Interventional

Funder types

Other

Identifiers

NCT00878540
L2/2008
EudraCT-Nr.: 2008-002704-26

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

Male

Ages

20 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

mirtazapine
Experimental group
Treatment:
Drug: mirtazapine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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