HealthyPhase 1SMMSNCT00878540
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
A Phase 1 study testing mirtazapine in people with Healthy, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mirtazapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 1
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Age 20-25 years
- Somatically and mentally healthy
- Normal body weight (body mass index (BMI)18.5-25)
Who cannot join
- Smoking within the last 6 months
- Medication within last 6 months
- Current or former psychiatric illness
- Positive family history (first grade relatives) for metabolic diseases
- Alcohol abuse
- Current or former illicit drug abuse
Show all 16Show fewer
- Current or former drug abuse
- Known intolerance to, or former prescription of study medication
- Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months
- Homelessness
- Shift work within last 12 months
- Known hypersensitivity to mirtazapine or other components of the drug given
- Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease
- Known hematologic disease, especially agranulocytosis or leukopenia
- Blood donation within last 6 months prior to the begin of the study
- Hemoglobin below 13.5 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Mirtazapine in Healthy Subjects
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.
- Conditions
- Healthy
- Being tested
- mirtazapine
- Keywords
- mirtazapine, metabolism, depression, Healthy males
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirtazapineDrug
Also called Remergil
30 mg mirtazapine once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| mirtazapine | Experimental | Not described Receives: Drug: mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Investigators
- Florian Holsboer, MD, PhD, Principal investigator, Max Planck Institute of Psychiatry, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878540
- Sponsor's protocol ID
- L2/2008
- Other IDs
- EudraCT-Nr.: 2008-002704-26
- Acronym
- SMMS
- Status last verified
- Sep 2010
- First submitted
- 8 Apr 2009
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lechner K, Heel S, Uhr M, Dose T, Holsboer F, Lucae S, Schaaf L, Fulda S, Kloiber S, Hennings JM. Weight-gain independent effect of mirtazapine on fasting plasma lipids in healthy men. Naunyn Schmiedebergs Arch Pharmacol. 2023 Sep;396(9):1999-2008. doi: 10.1007/s00210-023-02448-y. Epub 2023 Mar 9.
PubMed 36890393Hennings JM, Heel S, Lechner K, Uhr M, Dose T, Schaaf L, Holsboer F, Lucae S, Fulda S, Kloiber S. Effect of mirtazapine on metabolism and energy substrate partitioning in healthy men. JCI Insight. 2019 Jan 10;4(1):e123786. doi: 10.1172/jci.insight.123786.
PubMed 30626746Fulda S, Kloiber S, Dose T, Lucae S, Holsboer F, Schaaf L, Hennings J. Mirtazapine provokes periodic leg movements during sleep in young healthy men. Sleep. 2013 May 1;36(5):661-9. doi: 10.5665/sleep.2622.
PubMed 23633748
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Mirtazapine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00878540
- Acronym / sponsor ID
- SMMS / L2/2008
- Conditions
- Healthy
- Keywords
- mirtazapine, metabolism, depression, Healthy males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Apr 2009 (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.
The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirtazapine | Experimental | Drug: mirtazapine |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male sex
- Age 20-25 years
- Somatically and mentally healthy
- Normal body weight (body mass index (BMI)18.5-25)
Key exclusion criteria (16 listed)
- Smoking within the last 6 months
- Medication within last 6 months
- Current or former psychiatric illness
- Positive family history (first grade relatives) for metabolic diseases
- Alcohol abuse
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 |
|---|---|---|
| mirtazapineAlso: Remergil30 mg mirtazapine once daily for 7 days | Drug | mirtazapine |
Primary outcome
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
Time frame: 3 days
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 16 Sep 2010.
- Derived from this study: PubMed 36890393Lechner K, Heel S, Uhr M, Dose T, Holsboer F, Lucae S, Schaaf L, Fulda S, Kloiber S, Hennings JM. Weight-gain independent effect of mirtazapine on fasting plasma lipids in healthy men. Naunyn Schmiedebergs Arch Pharmacol. 2023 Sep;396(9):1999-2008. doi: 10.1007/s00210-023-02448-y. Epub 2023 Mar 9.
- Derived from this study: PubMed 30626746Hennings JM, Heel S, Lechner K, Uhr M, Dose T, Schaaf L, Holsboer F, Lucae S, Fulda S, Kloiber S. Effect of mirtazapine on metabolism and energy substrate partitioning in healthy men. JCI Insight. 2019 Jan 10;4(1):e123786. doi: 10.1172/jci.insight.123786.
- Derived from this study: PubMed 23633748Fulda S, Kloiber S, Dose T, Lucae S, Holsboer F, Schaaf L, Hennings J. Mirtazapine provokes periodic leg movements during sleep in young healthy men. Sleep. 2013 May 1;36(5):661-9. doi: 10.5665/sleep.2622.
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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.
Florian Holsboer, MD, PhD principal investigator
Max Planck Institute of Psychiatry, Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mirtazapine in people with Healthy, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
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 4 inclusion and 16 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 16 Sep 2010. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878540, which also lists 3 linked publications.
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 16 Sep 2010.