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NCT00613470 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 927
- Enrollment target
NCT00613470: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00613470 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 927 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613470, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 927 participants
- Enrollment target
Study Summary
This study is one component of a larger U01 grant that was submitted in August, 2004 to the NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients over 4 years. It is known that functionally significant genetic polymorphisms for the cytochrome P450 (CYPs) can contribute to individual differences in response to specific selective serotonin reuptake inhibitors (SSRIs). However, a better understanding of the pharmacogenomics of both PK and PD for SSRI antidepressants will inform clinical practice. Therefore, we propose to evaluate the contribution of pharmacogenomics to variation in response to the highly specific SSRIs citalopram (a racemic mixture) and escitalopram (a chiral compound containing the active S-isomer of citalopram ) by correlating both PK and PD variation for these agents with intragene haplotypes in genes encoding proteins involved in citalopram metabolism, as well as central nervous system (CNS) pathways for monoamine neurotransmitter biosynthesis, metabolism, storage, release, reuptake, and receptors. In the future this "candidate pathway" intragene haplotype genotyping strategy will also be complemented by the application of genome-wide screens performed with DNA from subjects with extreme phenotypes for response to citalopram. Phenotypes to be measured before and after the initiation of citalopram or escitalopram therapy will include determinations of serum citalopram and metabolite concentrations, treatment response as measured by Hamilton Rating Scale for Depression indices, and number and severity of side effects as determined by structured questionnaires. The hypothesis to be tested is that inherited variation in citalopram metabolism and transport (PK) and/or PD variation as a result of inherited variation in monoamine neurotransmitter biosynthesis, metabolism, reuptake, storage, receptors or signaling contribute to individual variation in citalopram antidepressant efficacy and/or side effects.
Interventions
- DRUG citalopram and escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 927 participants |
| Start Date | 2005-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613470
The ClinicalTrials.gov registry entry for NCT00613470 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 927 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which citalopram and escitalopram is the first listed.
NCT00613470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00613470 about?
NCT00613470 is a clinical study titled "Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram". This study is one component of a larger U01 grant that was submitted in August, 2004 to the NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients over 4 years. It is known that functionally significant genetic polymorphisms for the cytochrome P450 (CYPs) can co...
What is the current status of trial NCT00613470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 927 participants. The study started on 2005-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00613470?
The interventions under investigation include: citalopram and escitalopram (DRUG).
Who is sponsoring clinical trial NCT00613470?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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