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

NCT ID: NCT00627510

Last Updated: 2008-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-12-31

Brief Summary

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.

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.

Conditions

Depression; Affective Disorders, Psychotic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

A

all patients consecutively admitted to psychiatric inpatient treatment (naturalistic sample from routine psychiatric hospital intake)

Routine psychiatric inpatient treatment

Intervention Type: OTHER

Routine psychiatric inpatient treatment. This is not an interventional study.

Interventions

Routine psychiatric inpatient treatment

Routine psychiatric inpatient treatment. This is not an interventional study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• eligible for psychiatric inpatient treatment

Exclusion Criteria

• not eligible for psychiatric inpatient treatment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Medical University Innsbruck

Principal Investigators

Gerald Zernig, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Department of Psychiatry I, Paracelsus Medical University

Salzburg, Salzburg, Austria

Countries

Austria

Other Identifiers

PMUPSY20050001

Identifier Type: -

Identifier Source: org_study_id