Mental Disorders Clinical Trial
Official title:
Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans
Verified date | April 2007 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Psychiatric Research, Psychiatric Hospital of Aarhus University | Risskov |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Fund for Advancement of Medical Science, Max Woerzner's Research Award, The Danish Medical Research Council |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Binding potential in brain regions at tine of each PET scan | |||
Primary | Serum concentration at time of each PET scan |
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