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

Tracking Information

First Received Date ^ICMJE

April 8, 2009

Last Updated Date

September 15, 2010

Start Date ^ICMJE

September 2008

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00878540 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Official Title ^ICMJE

Phase 1 Study of Mirtazapine in Healthy Subjects

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: mirtazapine

30 mg mirtazapine once daily for 7 days

Other Name: Remergil

Study Arm (s)

Experimental: mirtazapine

Intervention: Drug: mirtazapine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00878540

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Responsible Party

Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry

Study Sponsor ^ICMJE

Max-Planck-Institute of Psychiatry

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Florian Holsboer, MD, PhD

Max Planck Institute of Psychiatry, Munich

Information Provided By

Max-Planck-Institute of Psychiatry

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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