Test Catalog

Test Id : CLOM

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Clomipramine, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining whether a poor therapeutic response is attributable to noncompliance

 

Monitoring serum concentration of clomipramine and norclomipramine to assist in optimizing the administered dose

Method Name
A short description of the method used to perform the test

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Clomipramine, S

Aliases
Lists additional common names for a test, as an aid in searching

Anafranil (Clomipramine)

Clomipramine (Anafranil)

Norclomipramine

TCA (Tricyclic Antidepressants)

Tricyclic Antidepressants (TCA)

Desmethylclomipramine (Norclomipramine)

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube: Red top (Serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Collect specimen immediately before next scheduled dose (minimum 12 hours after last dose).

2. Centrifuge and aliquot serum into a plastic vial. Serum must be separated from cells within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.25

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining whether a poor therapeutic response is attributable to noncompliance

 

Monitoring serum concentration of clomipramine and norclomipramine to assist in optimizing the administered dose

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Clomipramine (chlorimipramine, Anafranil) is a tricyclic antidepressant drug used primarily to treat obsessive-compulsive disorder. Clomipramine is also used to treat panic disorder and treatment-resistant depression.

 

Clomipramine preferentially blocks synaptic reuptake of serotonin; its pharmacologically active metabolite, norclomipramine (desmethylclomipramine) preferentially blocks synaptic reuptake of norepinephrine.

 

Clomipramine undergoes significant first-pass hepatic metabolism (up to 50%), which probably explains the high degree of interindividual variability observed between administered dose and steady-state serum concentrations of the drug and its metabolite. The serum ratio of clomipramine to norclomipramine is typically 1:2 to 1:2.5. The elimination half-lives of clomipramine and norclomipramine are 19 to 37 hours and 54 to 77 hours, respectively. When a patient is started on clomipramine or following an alteration in the dose, 1 to 2 weeks are required to achieve a steady-state condition.

 

Anticholinergic side effects (ie, dry mouth, excessive sweating, blurred vision, urinary retention, constipation) frequently accompany treatment. Other side effects may include tremor, nausea, orthostatic hypotension, dizziness, sexual dysfunction, and sleep disturbances. Signs and symptoms following overdose are similar to other tricyclic antidepressant drugs with cardiac toxicity (eg, tachycardia, arrhythmia, impaired conduction, congestive heart failure) the major concern.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Clomipramine and norclomipramine

Therapeutic concentration: 230-450 ng/mL

 

Note: Therapeutic ranges are for specimens collected at trough (ie, immediately before next scheduled dose). Levels may be elevated in non-trough specimens.

Interpretation
Provides information to assist in interpretation of the test results

Studies investigating the relationship between serum concentrations of clomipramine and norclomipramine and therapeutic response have yielded conflicting results. However, the probability of therapeutic failure seems to increase if the sum of the clomipramine and norclomipramine serum concentrations is less than 230 ng/mL. Summed serum concentrations of clomipramine and norclomipramine that exceed 450 ng/mL seem to result in no additional enhancement in therapeutic response and may predispose the patient to greater risk of adverse side effects. A toxic range has not been well established at this time.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test cannot be performed on whole blood. Serum must be separated from cells within 2 hours of collection; if serum is not removed within this time, tricyclic antidepressant levels may be falsely elevated due to drug release from red blood cells.

 

Specimens that are obtained from gel tubes are not acceptable because the drug can absorb on the gel and lead to falsely decreased concentrations.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Wille SM, Cooreman SG, Neels HM, Lambert WE. Relevant issues in the monitoring and the toxicology of antidepressants. Crit Rev Clin Lab Sci. 2008;45(1):25-89

2. Thanacoody HK, Thomas SHL. Antidepressant poisoning. Clin Med (Lond). 2003;3(2):114-118

3. Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51:9-62

4. Milone MC, Shaw LM. Therapeutic drugs and their management. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:420-453

Method Description
Describes how the test is performed and provides a method-specific reference

The tricyclic antidepressants are extracted from serum using a solvent to precipitate proteins. The supernatant is removed, and analysis is by liquid chromatography tandem mass spectrometry.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Wednesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CLOM Clomipramine, S 43127-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
80902 Clomipramine 3491-8
7983 Norclomipramine 3536-0
7984 Clomipramine + Norclomipramine 3493-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports