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

NCT00627510 | Completed DMC

• 1 other identifier: PMUPSY20050001
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

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?

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• There is NO secondary outcome measure.

  at admission

Study Arms (1)

A

all patients consecutively admitted to psychiatric inpatient treatment (naturalistic sample from routine psychiatric hospital intake)

Other: Routine psychiatric inpatient treatment

Interventions

Routine psychiatric inpatient treatment OTHER

Routine psychiatric inpatient treatment. This is not an interventional study.

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients consecutively admitted for routine psychiatric inpatient treatment

You may qualify if:

• eligible for psychiatric inpatient treatment

You may not qualify if:

• not eligible for psychiatric inpatient treatment

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Psychiatry I, Paracelsus Medical University

Salzburg, Salzburg, A-5020, Austria

Location

MeSH Terms

Conditions

Depression; Affective Disorders, Psychotic; Treatment Adherence and Compliance; Patient Compliance

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Patient Acceptance of Health Care

Study Officials

• Gerald Zernig, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: June 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: December 1, 2007
• Last Updated: March 3, 2008

Record last verified: 2008-02

Locations

AU (1)