Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression Affective Disorders, Psychotic |
Other: Routine psychiatric inpatient treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
- 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 ] [ Designated as safety issue: No ]
- There is NO secondary outcome measure. [ Time Frame: at admission ] [ Designated as safety issue: No ]
| Enrollment: | 161 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
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.
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients consecutively admitted for routine psychiatric inpatient treatment
Inclusion Criteria:
- eligible for psychiatric inpatient treatment
Exclusion Criteria:
- not eligible for psychiatric inpatient treatment
Contacts and Locations| Austria | |
| Department of Psychiatry I, Paracelsus Medical University | |
| Salzburg, Austria, A-5020 | |
| Principal Investigator: | Gerald Zernig, MD | Medical University Innsbruck |
More Information
No publications provided
| Responsible Party: | Gerald Zernig, Assoc.Prof.Pharmacology, Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00627510 History of Changes |
| Other Study ID Numbers: | PMUPSY20050001 |
| Study First Received: | February 22, 2008 |
| Last Updated: | February 22, 2008 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University Innsbruck:
|
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? |
Additional relevant MeSH terms:
|
Affective Disorders, Psychotic Depression Depressive Disorder Mental Disorders Psychotic Disorders Mood Disorders Behavioral Symptoms |
Schizophrenia and Disorders with Psychotic Features Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013