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Specific Effects of Escitalopram on Neuroendocrine Response

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ClinicalTrials.gov Identifier: NCT00150527
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 5, 2009
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Queen's University

Study Description
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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.

Condition or disease Intervention/treatment
Healthy Drug: Citalopram Drug: Escitalopram Drug: Dexamethasone Behavioral: Cold Pressor Test

Detailed Description:
See above.

Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Effects of Escitalopram on Neuroendocrine Response
Study Start Date : September 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Citalopram
    40 mg, pill, single dose
    Other Name: Celexa
  • Drug: Escitalopram
    20 mg, pill, single dose
  • Drug: Dexamethasone
    1 mg, pill, single dose
  • Behavioral: Cold Pressor Test
    single test

Outcome Measures
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Primary Outcome Measures :
  1. The effect of the drugs on serum cortisol and ACTH following a single dose of each drug. [ Time Frame: 4hrs ]

Secondary Outcome Measures :
  1. Side effects following a single dose of the drug [ Time Frame: 4hrs ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal healthy people
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150527


Locations
Canada, Ontario
Providence Centre, Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
H. Lundbeck A/S
Investigators
Principal Investigator: Nicholas J Delva, MD Queen's University
More Information
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Responsible Party: Dr. Nicholas Delva, Dalhousie University
ClinicalTrials.gov Identifier: NCT00150527     History of Changes
Other Study ID Numbers: ESCIT001
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by Queen's University:
antidepressive agents

Additional relevant MeSH terms:
Dexamethasone
Dexetimide
Citalopram
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents