Specific Effects of Escitalopram on Neuroendocrine Response

This study has been completed.
H. Lundbeck A/S
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
First received: September 6, 2005
Last updated: February 4, 2009
Last verified: February 2009
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.

Condition Intervention
Drug: Citalopram
Drug: Escitalopram
Drug: Dexamethasone
Behavioral: Cold Pressor Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Effects of Escitalopram on Neuroendocrine Response

Resource links provided by NLM:

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • The effect of the drugs on serum cortisol and ACTH following a single dose of each drug. [ Time Frame: 4hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects following a single dose of the drug [ Time Frame: 4hrs ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Citalopram
    40 mg, pill, single dose
    Other Name: Celexa
    Drug: Escitalopram
    20 mg, pill, single dose
    Other Name: unknown
    Drug: Dexamethasone
    1 mg, pill, single dose
    Other Name: unknown
    Behavioral: Cold Pressor Test
    single test
    Other Name: unknown
Detailed Description:
See above.

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal healthy people

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150527

Canada, Ontario
Providence Centre, Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
H. Lundbeck A/S
Principal Investigator: Nicholas J Delva, MD Queen's University
  More Information

Responsible Party: Dr. Nicholas Delva, Dalhousie University
ClinicalTrials.gov Identifier: NCT00150527     History of Changes
Other Study ID Numbers: ESCIT001 
Study First Received: September 6, 2005
Last Updated: February 4, 2009
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
antidepressive agents

Additional relevant MeSH terms:
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on May 30, 2016