Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission

Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission for Determination of Compliance and/or Speed of Drug Metabolism

Compliance with treatment is notoriously low in psychiatric patients. Traditional methods of monitoring compliance, however, may underreport nonadherence to treatment. In this study, actual plasma levels at admission - which are ROUTINELY taken at the Dept Psychiatry of the Paracelsus Medical University - were compared to plasma levels that can be expected from the prescribed preadmission dosing regimen. This was done to give treating psychiatrists a quantitatively precise idea of how frequently they can expect their patients to have plasma levels that are below the level of medication as intended by the prescribing physician.

Study Overview

• Status: Completed
• Conditions: Depression; Affective Disorders, Psychotic
• Intervention / Treatment: Other: Routine psychiatric inpatient treatment

Detailed Description

Context Noncompliance or incomplete compliance with psychopharmacological medication by psychiatric patients is a frequent risk and may be underreported by classical methods (e.g., pill counts or coloring additives).

Objective To determined the prevalence of incomplete compliance and/or faster-than average elimination of the medication by comparing actual plasma levels with those expected from the prescribed dosage under naturalistic routine conditions.

Design Forty-five day prospective routine survey.

Setting University acute inpatient clinic.

Participants All consecutive admissions for acute inpatient treatment from June 1, 2005 to July 15, 2005 who had been treated with antidepressants and/or antipsychotics.

Intervention Determination of plasma levels of all psychiatric medications and their comparison to the expected plasma levels, based on known preadmission dosing regimen and average pharmacokinetic data.

Main outcome measures The percentage of admissions with actual plasma level that were (a) more than 2-fold lower or (b) more than 2-fold higher than the expected plasma level or (c) differing only 0.5- to 2-fold from the expected plasma level.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, A-5020
    • Department of Psychiatry I, Paracelsus Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients consecutively admitted for routine psychiatric inpatient treatment

Description

Inclusion Criteria:

• eligible for psychiatric inpatient treatment

Exclusion Criteria:

• not eligible for psychiatric inpatient treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; all patients consecutively admitted to psychiatric inpatient treatment (naturalistic sample from routine psychiatric hospital intake)	Other: Routine psychiatric inpatient treatment; Routine psychiatric inpatient treatment. This is not an interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of admissions with actual plasma level that were (a) more than 2-fold lower or (b) more than 2-fold higher than the expected plasma level or (c) differing only 0.5- to 2-fold from the expected plasma level.	at admission to psychiatric inpatient treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
There is NO secondary outcome measure.	at admission

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Gerald Zernig, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): July 1, 2005
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: February 22, 2008
• First Submitted That Met QC Criteria: February 22, 2008
• First Posted (ESTIMATE): March 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2008
• Last Update Submitted That Met QC Criteria: February 22, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Compliance; Antidepressant; Antipsychotic; Metabolism; Treatment adherence; Therapeutic Drug Monitoring (TDM); Do patients take their psychiatric medication as prescribed?; Do psychiatric patients metabolize their medication faster than expected?; What are the exact odds that the patient of a physician prescribing antidepressants or antipsychotics has plasma levels that are BELOW those intended?
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Mood Disorders; Affective Disorders, Psychotic
• Other Study ID Numbers: PMUPSY20050001