IRB Number:

170-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

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.

Who is Eligible to Participate in the Study?

Diagnosis of major depressive disorder without psychosis or mania
Antidepressant treatment deemed appropriate

Minimum Age:

18

Maximum Age:

85

What is Involved With this Study?

Three visits to the clinic for structured interviews and blood sample collection.
Study medication for 8 weeks at no charge
$100 remuneration for completion of the study

How long will the Study run?

8 or 9 weeks with follow-up phone call at 24 weeks

pager 538-9212

Who can I Contact for Additional Information on this Trial?

Michelle Skime, 507-255-0501, skime.michelle@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 02/04/2008