Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
NCT ID: NCT00878540
Last Updated: 2010-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-09-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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mirtazapine
mirtazapine
30 mg mirtazapine once daily for 7 days
Interventions
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mirtazapine
30 mg mirtazapine once daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 20-25 years
* Somatically and mentally healthy
* Normal body weight (body mass index (BMI)18.5-25)
Exclusion Criteria
* 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
20 Years
25 Years
MALE
Yes
Sponsors
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Max-Planck-Institute of Psychiatry
OTHER
Responsible Party
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Max-Planck-Institute of Psychiatry
Principal Investigators
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Florian Holsboer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Max Planck Institute of Psychiatry, Munich
Locations
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Max Planck Institue of Psychiatry
Munich, , Germany
Countries
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References
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Lechner K, Heel S, Uhr M, Dose T, Holsboer F, Lucae S, Schaaf L, Fulda S, Kloiber S, Hennings JM. Weight-gain independent effect of mirtazapine on fasting plasma lipids in healthy men. Naunyn Schmiedebergs Arch Pharmacol. 2023 Sep;396(9):1999-2008. doi: 10.1007/s00210-023-02448-y. Epub 2023 Mar 9.
Hennings JM, Heel S, Lechner K, Uhr M, Dose T, Schaaf L, Holsboer F, Lucae S, Fulda S, Kloiber S. Effect of mirtazapine on metabolism and energy substrate partitioning in healthy men. JCI Insight. 2019 Jan 10;4(1):e123786. doi: 10.1172/jci.insight.123786.
Fulda S, Kloiber S, Dose T, Lucae S, Holsboer F, Schaaf L, Hennings J. Mirtazapine provokes periodic leg movements during sleep in young healthy men. Sleep. 2013 May 1;36(5):661-9. doi: 10.5665/sleep.2622.
Other Identifiers
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EudraCT-Nr.: 2008-002704-26
Identifier Type: -
Identifier Source: secondary_id
L2/2008
Identifier Type: -
Identifier Source: org_study_id