PET Neuroimaging of [11C]Mirtazapine

NCT00288782 | Completed Phase 4

• 1 other identifier: Mirtazapine_Occupancy_01_2005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mirtazapine; Antidepressant; Positron Emission Tomography

Outcome Measures

Primary Outcomes (2)

• Binding potential in brain regions at tine of each PET scan

• Serum concentration at time of each PET scan

Interventions

Mirtazapine DRUG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• PET scanned during past year
• Chronic illness
• Daily use of drug
• Mental illness
• Abnormal value in routine blood analysis
• Pregnancy
• Breast feeding

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Medical Research Council: collaborator
• Fund for Advancement of Medical Science: collaborator
• Max Woerzner's Research Award: collaborator

Study Sites (1)

Center for Psychiatric Research, Psychiatric Hospital of Aarhus University

Risskov, 8240, Denmark

Location

MeSH Terms

Conditions

Mental Disorders; Mood Disorders; Depressive Disorder

Interventions

Mirtazapine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Donald F Smith, PhD, DMSc

  Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: February 1, 2006
• Study Completion: April 1, 2007
• Last Updated: April 19, 2007

Record last verified: 2007-04

Locations

DK (1)