Specific Effects of Escitalopram on Neuroendocrine Response

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00150527
First received: September 6, 2005
Last updated: February 4, 2009
Last verified: February 2009
  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: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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:
Antidepressive Agents
Citalopram
Dexetimide
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Antiemetics
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 27, 2014