PET Neuroimaging of [11C]Mirtazapine

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.

Conditions

• Mental Disorders
• Mood Disorders
• Affective Disorders
• Depressive Disorders

Interventions

DRUG

Mirtazapine

Sponsors & Collaborators

• The Danish Medical Research Council

  collaborator OTHER

• Fund for Advancement of Medical Science

  collaborator UNKNOWN

• Max Woerzner's Research Award

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

• Donald F Smith, PhD, DMSc · Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-02-28

Completion

2007-04-30

Countries

• Denmark

Study Locations