Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/13/2017 |
| Start Date: | October 2001 |
| End Date: | December 2015 |
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.
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.
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.
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.
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
We found this trial at
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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