Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission
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|ClinicalTrials.gov Identifier: NCT00627510|
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : March 3, 2008
|Condition or disease||Intervention/treatment|
|Depression Affective Disorders, Psychotic||Other: Routine psychiatric inpatient treatment|
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|
|Actual Enrollment :||161 participants|
|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 Start Date :||June 2005|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||December 2007|
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.
- 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. [ Time Frame: at admission to psychiatric inpatient treatment ]
- There is NO secondary outcome measure. [ Time Frame: at admission ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627510
|Department of Psychiatry I, Paracelsus Medical University|
|Salzburg, Austria, A-5020|
|Principal Investigator:||Gerald Zernig, MD||Medical University Innsbruck|