Relationship Between Neurotransmitter Receptor Polymorphisms, Plasma Concentrations and Clinical Response to Clozapine
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ClinicalTrials.gov Identifier: NCT00581932 |
Recruitment Status
:
Completed
First Posted
: December 28, 2007
Last Update Posted
: May 12, 2017
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Condition or disease |
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Schizophrenia |
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 |

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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- Brief Psychiatric Rating Scale [ Time Frame: entry, 3 wks, 5 wks, 8 wks, 4 mo, 6 mo ]
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
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:
clozapine, schizophrenia |
Additional relevant MeSH terms:
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 |