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Completed

NCT Number: NCT00150527

Specific Effects of Escitalopram on Neuroendocrine Response

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.

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Key information

Conditions

Healthy

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Providence Centre, Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

About this study

See above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Citalopram

Drug

40 mg, pill, single dose

Other names: Celexa

Escitalopram

Drug

20 mg, pill, single dose

Dexamethasone

Drug

1 mg, pill, single dose

Cold pressor test

Behavioral

single test

Primary outcomes

  1. The effect of the drugs on serum cortisol and ACTH following a single dose of each drug.

    Time frame: 4hrs

Secondary outcomes

  1. Side effects following a single dose of the drug

    Time frame: 4hrs

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Sep 8, 2005
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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