Specific Effects of Escitalopram on Neuroendocrine Response

NCT ID: NCT00150527

Last Updated: 2009-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-12-31

Brief Summary

Citalopram, a selective serotonin reuptake inhibitor (SSRI), is used as a neuroendocrine probe in human subjects to assess serotonin (5-hydroxytryptamine; 5-HT) function as reflected in prolactin and plasma cortisol release. Citalopram is a racemic mixture of equal parts of the S(+) and R(-) enantiomers. The S(+) form ("escitalopram") has been identified as being the active isomer and inhibitor of serotonin reuptake and consequently antidepressant activity is associated almost exclusively with the S-enantiomer. Escitalopram has been shown to be approximately twice as potent as citalopram at the primary, high-affinity binding site on the human serotonin transporter. Interestingly, investigations have suggested an antagonistic interaction of the R- and S-enantiomer at an allosteric binding site on the serotonin transporter. This antagonism has been shown in animal studies where the addition of R-citalopram to escitalopram treatments significantly counteracts the antidepressant and anti-anxiolytic effects of escitalopram. From these clinical and experimental data, the researchers can anticipate that escitalopram would increase cortisol and prolactin in the neuroendocrine challenge paradigm more effectively than citalopram.

Detailed Description

See above.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Citalopram

40 mg, pill, single dose

Intervention Type: DRUG

Escitalopram

20 mg, pill, single dose

Intervention Type: DRUG

Dexamethasone

1 mg, pill, single dose

Intervention Type: DRUG

Cold Pressor Test

single test

Intervention Type: BEHAVIORAL

Other Intervention Names

Celexa

Eligibility Criteria

Inclusion Criteria

• The age range will be restricted to between 18 and 59 years of age.
• Subjects must be fit and have no history of significant illness.
• Subjects must have no risk factors for HIV or viral hepatitis.
• Subjects must be non-smokers, free of medication, and consume alcoholic and caffeinated beverages in moderation.
• Subjects must also be in good psychological health with no history of psychiatric illness.

Exclusion Criteria

• Personal history of psychiatric illness, habitual smoking, illicit or prescription drug use, high intake of alcohol (>10 drinks/week) or caffeine (>500 mg caffeine/day), shift work, pregnancy, personal or familial history of seizures, significant medical illness or treatment in the last six months, significant physical or laboratory abnormalities, or current use of a weight loss diet.
• Women entering the study must be on a reliable form of birth control, i.e., tubal ligation, hysterectomy, oral contraceptives, abstinence, or vasectomy in partner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dalhousie University

Principal Investigators

Nicholas J Delva, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Providence Centre, Mental Health Services

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

ESCIT001

Identifier Type: -

Identifier Source: org_study_id