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

This study has been completed.
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00627510
First received: February 22, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary 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. [ Time Frame: at admission to psychiatric inpatient treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

patients consecutively admitted for routine psychiatric inpatient treatment

Criteria

Inclusion Criteria:

  • eligible for psychiatric inpatient treatment

Exclusion Criteria:

  • not eligible for psychiatric inpatient treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00627510

Locations
Austria
Department of Psychiatry I, Paracelsus Medical University
Salzburg, Austria, A-5020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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:
Depression
Mood Disorders
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 29, 2014