Specific Effects of Escitalopram on Neuroendocrine Response

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

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

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

• Responsible Party: Dr. Nicholas Delva, Dalhousie University
• ClinicalTrials.gov Identifier: NCT00150527
• Other Study ID Numbers: ESCIT001
• First Posted: September 8, 2005
• Last Update Posted: February 5, 2009
• Last Verified: February 2009

Keywords provided by Queen's University:

antidepressive agents

Additional relevant MeSH terms:

Dexamethasone; 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