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Specific Effects of Escitalopram on Neuroendocrine Response

Specific Effects of Escitalopram on Neuroendocrine Response

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00150527
Enrollment
8
Registered
2005-09-08
Start date
2005-09-30
Completion date
2007-12-31
Last updated
2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

antidepressive agents

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.

Interventions

DRUGCitalopram

40 mg, pill, single dose

DRUGEscitalopram

20 mg, pill, single dose

DRUGDexamethasone

1 mg, pill, single dose

BEHAVIORALCold Pressor Test

single test

Sponsors

H. Lundbeck A/S
CollaboratorINDUSTRY
Queen's University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The effect of the drugs on serum cortisol and ACTH following a single dose of each drug.4hrs

Secondary

MeasureTime frame
Side effects following a single dose of the drug4hrs

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026