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Sponsors and Collaborators: |
Mayo Clinic National Institutes of Health (NIH) |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00613470 |
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.
Condition | Intervention |
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Depression |
Drug: citalopram and escitalopram |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
Official Title: | Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram |
Estimated Enrollment: | 1200 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
escitalopram tablets starting at 10 mg, increase to 20 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
citalopram tablet or solution starting at 2o mg, increase to 40 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnant subjects will be excluded.
Contact: Michelle K Skime, CCRP | 507-255-0501 | skime.michelle@mayo.edu |
Contact: Karen A Snyder, BS | 507-266-8749 | snyder.karen@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Michelle K Skime, CCRP 507-255-0507 skime.michelle@mayo.edu | |
Principal Investigator: David A Mrazek, M.D. |
Principal Investigator: | David A. Mrazek, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic Rochester ( David A. Mrazek ) |
Study ID Numbers: | 170-05, GM1388-081 |
Study First Received: | January 30, 2008 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00613470 History of Changes |
Health Authority: | United States: Institutional Review Board |
Depression Antidepressants |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Cholinergic Agents Depressive Disorder Citalopram Serotonin Uptake Inhibitors Serotonin |
Behavioral Symptoms Muscarinic Antagonists Mental Disorders Mood Disorders Peripheral Nervous System Agents Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Mental Disorders Therapeutic Uses Antidepressive Agents, Second-Generation Dexetimide |
Antidepressive Agents Depression Depressive Disorder Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents Autonomic Agents Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |