PET Neuroimaging of [11C]Mirtazapine
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mental Disorders; Mood Disorders; Affective Disorders; Depressive Disorders
Intervention: Mirtazapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Donald F Smith, PhD, DMSc, Principal Investigator, Affiliation: Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark
Summary
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.
Clinical Details
Official title: Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans
Study design: Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Binding potential in brain regions at tine of each PET scanSerum concentration at time of each PET scan
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
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Center for Psychiatric Research, Psychiatric Hospital of Aarhus University, Risskov 8240, Denmark
Additional Information
Starting date: February 2006
Ending date: April 2007
Last updated: April 18, 2007
|
