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

September 15, 2010 updated by: Max-Planck-Institute of Psychiatry

Phase 1 Study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany
        • Max Planck Institue of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mirtazapine
Drug: mirtazapine
30 mg mirtazapine once daily for 7 days
Other Names:
  • Remergil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max-Planck-Institute of Psychiatry

Investigators

  • Principal Investigator: Florian Holsboer, MD, PhD, Max Planck Institute of Psychiatry, Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2010

Last Update Submitted That Met QC Criteria

September 15, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on mirtazapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe