Short-term Metabolic Effects of Mirtazapine in Healthy Su... | NCT00878540

Studies
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

NCT00878540

Sponsor

Max-Planck-Institute of Psychiatry

Status

Completed

Last Update Posted

Sep 16, 2010Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

mirtazapine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT-Nr.: 2008-002704-26

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 8, 2009

First Submission Date that Met QC Criteria

Apr 8, 2009

First Posted Date

Apr 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2010

Last Update Posted Date

Sep 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Label	Type	Description	Intervention Names
mirtazapine	Experimental		Drug: mirtazapine

Name	Type	Description	Arm Group Labels	Other Names
mirtazapine	Drug	30 mg mirtazapine once daily for 7 days	mirtazapine

Measure	Description	Time Frame
Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male sex
Age 20-25 years
Somatically and mentally healthy
Normal body weight (body mass index (BMI)18.5-25)

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florian Holsboer, MD, PhD	Max Planck Institute of Psychiatry, Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Max Planck Institue of Psychiatry		Munich			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36890393	Derived	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.
30626746	Derived

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds