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

Completed

• Conditions: Depression; Affective Disorders, Psychotic
• Interventions: Other: Routine psychiatric inpatient treatment

• Registration Number: NCT00627510
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-07
• Study Completion: 2007-12
• Status Verified: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-22
• Last Update Submitted: 2008-02-22
• Study First Posted: 2008-03-03
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• eligible for psychiatric inpatient treatment

Exclusion Criteria

• not eligible for psychiatric inpatient treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Routine psychiatric inpatient treatment	all patients consecutively admitted to psychiatric inpatient treatment (naturalistic sample from routine psychiatric hospital intake)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
There is NO secondary outcome measure.	at admission

Trial Locations

Locations (1)

Department of Psychiatry I, Paracelsus Medical University; 🇦🇹 Salzburg, Austria