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Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine

Information source: University of Iowa
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Phase: N/A

Status: Recruiting

Sponsored by: Delwyn D. Miller

Official(s) and/or principal investigator(s):
Del D Miller, PharmD, M.D., Principal Investigator, Affiliation: The University of Iowa

Overall contact:
Timothy L Holman, M.A., Phone: 319-335-6769, Email: Timothy-Holman@uiowa.edu

Summary

This is a study designed to identify genetic polymorphisms (also called allelic variants or genetic markers) that are associated with response to clozapine. This information will be used to enhance the understanding of clozapine response and side effects. DNA from patients will be examined for significant associations between allelic variants in candidate genes in relation to clozapine effects on positive and negative symptoms, global response, quality of life, relapse rates and side effects.

Clinical Details

Official title: Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Brief Psychiatric Rating Scale

Secondary outcome:

Scale for the Assessment of Positive Symptoms

Scale for the assessment of Negative symptoms

Calgary Depression Scale

Abnormal Involuntary Movement Scale

Barnes Akathisia Scale

Detailed description: Patients age 18-65 with a DSM IV diagnosis of schizophrenia who have a history of nonresponse to conventional atypical antipsychotics and who are to be treated with clozapine by their psychiatrist, will be asked to participate at or near the time clozapine therapy is initiated. The Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Negative Symptoms (SANS), and the Scale for the Assessment of Positive Symptoms (SAPS) will be performed on all subjects at entry into the study, at 3 weeks, 5 weeks, 8 weeks, and at 4 and 6 months. Adverse effects will be monitored with the Simpson-Angus Scale, Barnes Akathisia scale and the AIMS at each of these time points. The Calgary Depression Scale will also be administered at each visit. A complete neurocognitive assessment battery will be completed at entry and at 6 months for those subjects willing to undergo neurocognitive testing. It is anticipated not all subjects will complete neurocognitive testing. A blood or cheek swab sample will be collected at study entry for DNA analysis. Plasma blood levels will be collected at weeks 3, 5, 8 and study completion for measurement of clozapine plasma concentrations. The subject's weight, BMI, smoking status and concomitant medications will be recorded at each visit.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of schizophrenia

- Beginning clozapine therapy

- age 18-65

- must be willing to participate in interviews and provide a DNA sample

Exclusion Criteria:

- no longer taking clozapine

Locations and Contacts

Timothy L Holman, M.A., Phone: 319-335-6769, Email: Timothy-Holman@uiowa.edu

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Timothy L Holman, M.A., Phone: 319-335-6769, Email: Timothy-Holman@uiowa.edu
Del D Miller, M.D., Phone: 319-353-4506, Email: Del-Miller@uiowa.edu
Del D Miller, PharmD., M.D., Principal Investigator
Timothy L Holman, M.A., Sub-Investigator
Jane J Kerr, B.S., Sub-Investigator
Additional Information

Starting date: October 2001
Last updated: June 22, 2012

Page last updated: August 20, 2015

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