Trial record 1 of 2 for:    Mirtazapine PET
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PET Neuroimaging of [11C]Mirtazapine

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
Fund for Advancement of Medical Science
Max Woerzner's Research Award
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00288782
First received: February 7, 2006
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

Recent studies show that 25 – 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions.

Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in “stress reactions” as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression.

The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.


Condition Intervention Phase
Mental Disorders
Mood Disorders
Affective Disorders
Depressive Disorders
Drug: Mirtazapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Binding potential in brain regions at tine of each PET scan
  • Serum concentration at time of each PET scan

Estimated Enrollment: 24
Study Start Date: February 2006
Study Completion Date: April 2007
Detailed Description:

This project uses a double-blind, placebo-controlled, parallel-group design to determine whether there is a reliable relationship between the level of the antidepressant drug mirtazapine in the bloodstream and the degree of occupancy of neuroreceptors in the brain of healthy human volunteers. The primary data endpoints of the study will be the binding potential of C-11 labelled racemic mirtazapine in the brain under baseline conditions and after 5 days of ingestion of either a placebo tablet or a table containing 7.5 mg or 15 mg of mirtazapine. The degree of receptor occupancy obtained during each experimental condition will be calculated on the basis of the binding potentials in brain regions using data obtained by positron emission tomography (PET scanning). Blood samples will be obtained at the time of PET scanning in order to determine whether there is a reliable correlation between the concentration of mirtazapine in the bloodstream and the degree of receptor occupancy achieved in brain. The study plans to include 24 healthy volunteers with 8 subjects in each of the three groups (placebo, 7.5 mg mirtazapine, and 15 mg mirtazapine). Subjects will be randomized into groups in such a way that each of the three treatments will be used for each of three consecutive subjects that enter the study. This procedure will reduce the possibility that differences in procedures that might occur over time will introduce bias into the results. Radiosynthesis of (C-11)mirtazapine will occur by the authorized and documented procedures currently established at the PET Center of Aarhus University Hospital.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • Drug-free
  • No cognitive impairment
  • Normal brain anatomy based on MRI
  • Contraceptive use by females

Exclusion Criteria:

  • PET scanned during past year
  • Chronic illness
  • Daily use of drug
  • Mental illness
  • Abnormal value in routine blood analysis
  • Pregnancy
  • Breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288782

Locations
Denmark
Center for Psychiatric Research, Psychiatric Hospital of Aarhus University
Risskov, Denmark, 8240
Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
Fund for Advancement of Medical Science
Max Woerzner's Research Award
Investigators
Principal Investigator: Donald F Smith, PhD, DMSc Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00288782     History of Changes
Other Study ID Numbers: Mirtazapine_Occupancy_01_2005
Study First Received: February 7, 2006
Last Updated: April 18, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Mirtazapine
Antidepressant
Positron Emission Tomography

Additional relevant MeSH terms:
Mirtazapine
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on September 30, 2014