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Specific Effects of Escitalopram on Neuroendocrine Response
This study has been completed.
First Received: September 6, 2005   Last Updated: February 4, 2009   History of Changes
Sponsor: Queen's University
Collaborator: H. Lundbeck A/S
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00150527
  Purpose

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
Healthy
Drug: Citalopram
Drug: Escitalopram
Drug: Dexamethasone
Behavioral: Cold Pressor Test

Study Type: Observational
Study Design: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
    Drug: Escitalopram
    20 mg, pill, single dose
    Drug: Dexamethasone
    1 mg, pill, single dose
    Behavioral: Cold Pressor Test
    single test
Detailed Description:

See above.

  Eligibility

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

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

No publications provided

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

Keywords provided by Queen's University:
antidepressive agents

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

ClinicalTrials.gov processed this record on February 08, 2010