Clinical trial NCT00627510: Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Affective Disorders, Psychotic
Keywords: Therapeutic Drug Monitoring (TDM)
Antidepressant
Antipsychotic
Treatment adherence
Compliance
Metabolism
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?
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients consecutively admitted for routine psychiatric inpatient treatment

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.

Eligibility criteria: Inclusion Criteria:

* eligible for psychiatric inpatient treatment

Exclusion Criteria:

* not eligible for psychiatric inpatient treatment

Primary outcomes:
measure: 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.
timeFrame: at admission to psychiatric inpatient treatment
Secondary outcomes:
measure: There is NO secondary outcome measure.
timeFrame: at admission
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Psychiatry I, Paracelsus Medical University
Study officials:
affiliation: Medical University Innsbruck
name: Gerald Zernig, MD
role: PRINCIPAL_INVESTIGATOR
References: