Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine
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| ClinicalTrials.gov Identifier: NCT00581932 |
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Recruitment Status :
Completed
First Posted : December 28, 2007
Last Update Posted : May 12, 2017
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Sponsor:
Delwyn D. Miller
Information provided by (Responsible Party):
Delwyn D. Miller, University of Iowa
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Brief 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.
| Condition or disease |
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| Schizophrenia |
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.
| Study Type : | Observational |
| Actual Enrollment : | 76 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine |
| Study Start Date : | October 2001 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Clozapine
| Group/Cohort |
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A
One group, all subjects with DSM-IV diagnosis of Schizophrenia, age 18-65 who are initiating clozapine therapy.
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Primary Outcome Measures :
- Brief Psychiatric Rating Scale [ Time Frame: entry, 3 wks, 5 wks, 8 wks, 4 mo, 6 mo ]
Secondary Outcome Measures :
- Scale for the Assessment of Positive Symptoms [ Time Frame: entry, wk 3, wk 5, wk 8, 4 mo, 6 mo ]
- Scale for the assessment of Negative symptoms [ Time Frame: entry, 3 wk, 5 wk, 8 wk, 4 mo, 6 mo ]
- Calgary Depression Scale [ Time Frame: entry, 3 wk, 5 wk, 8 wk, 4 mo, 6 mo ]
- Abnormal Involuntary Movement Scale [ Time Frame: entry, 3 wk, 5 wk, 8 wk, 4 mo, 6 mo ]
- Barnes Akathisia Scale [ Time Frame: entry, 3 wk, 5 wk, 8 wk, 4 mo, 6 mo ]
Biospecimen Retention: Samples With DNA
whole blood, saliva
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Psychiatric clinic, Inpatient Psychiatry unit
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581932
Locations
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
Sponsors and Collaborators
Delwyn D. Miller
Investigators
| Principal Investigator: | Del D Miller, PharmD, M.D. | The University of Iowa |
| Responsible Party: | Delwyn D. Miller, Professor, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00581932 History of Changes |
| Other Study ID Numbers: |
199901018 |
| First Posted: | December 28, 2007 Key Record Dates |
| Last Update Posted: | May 12, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Delwyn D. Miller, University of Iowa:
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clozapine, schizophrenia |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Clozapine Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents |