Mental DisordersPhase 4NCT00288782
PET Neuroimaging of [11C]Mirtazapine
A Phase 4 study testing Mirtazapine in people with Mental Disorders and Mood Disorders, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Mood Disorders, Affective Disorders
- What is being tested?
- Mirtazapine
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Drug-free
- No cognitive impairment
- Normal brain anatomy based on MRI
- Contraceptive use by females
Who cannot join
- PET scanned during past year
- Chronic illness
- Daily use of drug
- Mental illness
- Abnormal value in routine blood analysis
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Psychiatric Research, Psychiatric Hospital of Aarhus University
Risskov, 8240
About this study
Official title: Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans
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.
Read the 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.
- Being tested
- Mirtazapine
- Keywords
- Mirtazapine, Antidepressant, Positron Emission Tomography
- Medical subject headings
- Mental Disorders, Mood Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding potential in brain regions at tine of each PET scan
Serum concentration at time of each PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, Fund for Advancement of Medical Science, Max Woerzner's Research Award
- Investigators
- Donald F Smith, PhD, DMSc, Principal investigator, Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288782
- Sponsor's protocol ID
- Mirtazapine_Occupancy_01_2005
- Status last verified
- Apr 2007
- First submitted
- 7 Feb 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans
- ClinicalTrials.gov ID
- NCT00288782
- Acronym / sponsor ID
- Mirtazapine_Occupancy_01_2005
- Keywords
- Mirtazapine, Antidepressant, Positron Emission Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, Fund for Advancement of Medical Science, Max Woerzner's Research Award
- Study start
- Feb 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteer
- Drug-free
- No cognitive impairment
- Normal brain anatomy based on MRI
- Contraceptive use by females
Key exclusion criteria (7 listed)
- PET scanned during past year
- Chronic illness
- Daily use of drug
- Mental illness
- Abnormal value in routine blood analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine | Drug | – |
Primary outcome
Binding potential in brain regions at tine of each PET scan
Serum concentration at time of each PET scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
Related trials for Mental Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald F Smith, PhD, DMSc principal investigator
Center for Basic Psychiatric Research, Psychiatric Hospital of Aarhus University, Skovagervej 2, 8240 Risskov, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirtazapine in people with Mental Disorders and Mood Disorders, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binding potential in brain regions at tine of each PET scan. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.