Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

NCT00878540 | Completed Phase 1

• 2 other identifiers: L2/2008EudraCT-Nr.: 2008-002704-26
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

mirtazapine; metabolism; depression; Healthy males

Outcome Measures

Primary Outcomes (1)

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

  3 days

Study Arms (1)

mirtazapine

EXPERIMENTAL

Drug: mirtazapine

Interventions

mirtazapine DRUG

30 mg mirtazapine once daily for 7 days

Also known as: Remergil

mirtazapine

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex
• Age 20-25 years
• Somatically and mentally healthy
• Normal body weight (body mass index (BMI)18.5-25)

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institue of Psychiatry

Munich, Germany

Location

Related Publications (3)

• 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.

  PMID: 36890393 DERIVED

• 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.

  PMID: 30626746 DERIVED

• 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.

  PMID: 23633748 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Florian Holsboer, MD, PhD

  Max Planck Institute of Psychiatry, Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

DE (1)