PET Neuroimaging of [11C]Mirtazapine
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|ClinicalTrials.gov Identifier: NCT00288782|
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : April 19, 2007
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 or disease||Intervention/treatment||Phase|
|Mental Disorders Mood Disorders Affective Disorders Depressive Disorders||Drug: Mirtazapine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans|
|Study Start Date :||February 2006|
|Study Completion Date :||April 2007|
- Binding potential in brain regions at tine of each PET scan
- Serum concentration at time of each PET scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288782
|Center for Psychiatric Research, Psychiatric Hospital of Aarhus University|
|Risskov, Denmark, 8240|
|Principal Investigator:||Donald F Smith, PhD, DMSc||Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark|