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 SymptomsScale 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
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