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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627510
• Other study ID #: PMUPSY20050001
• Status: Completed
• Phase: N/A
• First received: February 22, 2008
• Last updated: February 22, 2008
• Start date: June 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• eligible for psychiatric inpatient treatment

Exclusion Criteria:

• not eligible for psychiatric inpatient treatment

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Depression
• Mental Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

Other:
• Routine psychiatric inpatient treatment
Routine psychiatric inpatient treatment. This is not an interventional study.

Locations

Country	Name	City	State
Austria	Department of Psychiatry I, Paracelsus Medical University	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	There is NO secondary outcome measure.		at admission	No